503B Docket

Recent FDA actions involving registered 503B facilities

This is a record of what FDA published, not a rating. Showing 167 dated actions since Oct 16, 2024 for facilities currently on FDA's list. Items marked uncertain may concern a related site.

  1. Form FDA 483 FDA table · Mark Cuban Cost Plus Manufacturing and Compounding, LLC Dallas, TX
    Form FDA 483 issued, per FDA's registration table (no document link published there)
    No document link published
  2. Form FDA 483 FDA table · Eagle Pharma Birmingham, AL
    Form FDA 483 issued, per FDA's registration table (no document link published there)
    No document link published
  3. Form FDA 483 FDA table · Leesar Inc. Fort Myers, FL
    Form FDA 483 issued, per FDA's registration table (no document link published there)
    No document link published
  4. Form FDA 483 FDA table · Assure Infusions, Inc. Bartow, FL
    Form FDA 483 issued, per FDA's registration table (no document link published there)
    No document link published
  5. Warning letter FDA table · SCA Pharmaceuticals Little Rock, AR
    Warning Letter Issued 9/14/2026
    No document link published
  6. Form FDA 483 Uncertain match · Right Value Drug Stores, LLC, dba Carie Boyd's Prescription Shop Irving, TX
    483 Issued 09/08/2026 (PDF - 1.34MB)
    Source
  7. Form FDA 483 FDA table · STAQ Pharma, Inc. Denver, CO
    Form FDA 483 issued, per FDA's registration table (no document link published there)
    No document link published
  8. Form FDA 483 FDA table · Olympia Pharmaceuticals Orlando, FL
    Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page ("483 Issued 09/03/2026 (PDF - 2MB)"). That listing is an uncertain match: Similar (not identical) name with same city and state
    Source
  9. Recall Matched · OurPharma LLC Fayetteville, AR
    Class II recall, 1 product line(s): Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product
    Source
  10. Form FDA 483 FDA table · RC Outsourcing, LLC Lowellville, OH
    Form FDA 483 issued, per FDA's registration table (no document link published there)
    No document link published
  11. Form FDA 483 FDA table · Apothecary Pharma, LLC Cary, NC
    Form FDA 483 issued, per FDA's registration table (no document link published there)
    No document link published
  12. Form FDA 483 FDA table · Tailstorm Health Inc. Chandler, AZ
    Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page ("483 Issued 08/28/2026 (PDF - 9.53MB)")
    Source
  13. Form FDA 483 FDA table · Hybrid Pharma, LLC Deerfield Beach, CA
    Form FDA 483 issued, per FDA's registration table (no document link published there)
    No document link published
  14. Form FDA 483 FDA table · STAQ Pharma of Ohio, LLC Columbus, OH
    Form FDA 483 issued, per FDA's registration table (no document link published there)
    No document link published
  15. Form FDA 483 FDA table · Imprimis NJOF, LLC Ledgewood, NJ
    Form FDA 483 issued, per FDA's registration table (no document link published there)
    No document link published
  16. Form FDA 483 FDA table · IntegraDose Compounding Services, LLC Shoreview, MN
    Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page ("483 Issued 08/12/2026 (PDF - 1.83MB)"). That listing is an uncertain match: Name and state match but a different city (Minneapolis, MN); may be another site of the same company
    Source
  17. Form FDA 483 FDA table · OurPharma LLC Fayetteville, AR
    Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page ("483 Issued 08/12/2026 (PDF - 1.64MB)")
    Source
  18. Warning letter FDA table · Pine Pharmaceuticals, LLC Tonawanda, NY
    Warning Letter Issued 8/7/2026
    No document link published
  19. Recall Matched · Apollo Care Columbia, MO
    Class II recall, 11 product line(s): Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
    Source
  20. Form FDA 483 FDA table · Apollo Care Columbia, MO
    Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page ("483 Issued 07/28/2026 (PDF - 1.60MB)")
    Source
  21. Warning letter close-out FDA table · MedisourceRx Los Alamitos, CA
    Warning Letter Closeout Issued 7/27/2026
    No document link published
  22. Warning letter close-out FDA table · Nubratori, Inc. Torrance, CA
    Warning Letter Closeout Issued 7/27/2026
    No document link published
  23. FMD-145 letter FDA table · Nubratori, Inc. Torrance, CA
    FMD-145 Letter Issued 7/21/2026
    No document link published
  24. Form FDA 483 FDA table · Brookfield Medical/Surgical Supply, Inc. Brookfield, CT
    Form FDA 483 (linked from FDA's registration table)
    Source
  25. Recall Matched · Quva Pharma, Inc. Sugar Land, TX
    Class II recall, 1 product line(s): Failed Impurities/Degradation Specifications
    Source
  26. Form FDA 483 Matched · Annovex Pharma, Inc. Lorton, VA
    Amended 483 Issued 06/18/2026 (PDF - 618 KB)
    Source
  27. FMD-145 letter FDA table · Wesley Pharmaceuticals Orlando, FL
    FMD-145 Letter Issued 6/17/2026
    No document link published
  28. Untitled letter FDA table · Denver Solutions, LLC, dba Leiters Health Englewood, CO
    Untitled Letter Issued 6/8/2026
    Source
  29. Form FDA 483 FDA table · Annovex Pharma, Inc. Lorton, VA
    Form FDA 483 (linked from FDA's registration table)
    Source
  30. Form FDA 483 FDA table · PQ Pharmacy LLC Brooksville, FL
    Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page ("483 Issued 06/01/2026 (PDF - 14 MB)")
    Source
  31. Form FDA 483 FDA table · SKNV formerly registered as Sincerus Florida, LLC Pompano Beach, FL
    Form FDA 483 (linked from FDA's registration table)
    Source
  32. Recall Matched · IntegraDose Compounding Services, LLC Shoreview, MN
    Class II recall, 1 product line(s): Subpotent Drug
    Source
  33. Recall Uncertain match · Aveva Drug Delivery Systems, Inc Tamarac, FL
    Class III recall, 1 product line(s): Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of i
    Source
  34. Warning letter FDA table · Fresenius Kabi Compounding LLC dba Fagron Sterile Services Canton, MA
    Warning Letter Issued 5/12/2026
    No document link published
  35. Recall Matched · IntegraDose Compounding Services, LLC Shoreview, MN
    Class II recall, 1 product line(s): Subpotent Drug
    Source
  36. Regulatory meeting FDA table · Park Avenue Compounding St. Louis, MO
    Regulatory Meeting Held 5/7/2026
    No document link published
  37. Form FDA 483 FDA table · Turbare Manufacturing Conway, AR
    Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page ("Amended 483 Issued 05/07/2026 (PDF - 2.67 MB)")
    Source
  38. Regulatory meeting FDA table · Central Admixture Pharmacy Services, Inc. Allentown, PA
    Regulatory Meeting Held 5/5/2026
    No document link published
  39. Regulatory meeting FDA table · Central Admixture Pharmacy Services Phoenix, AZ
    Regulatory Meeting Held 5/5/2026
    No document link published
  40. FMD-145 letter Matched · Quva Pharma, Inc. Sugar Land, TX
    FMD-145 Letter Issued 05/05/2026
    No document link published
  41. Form FDA 483 FDA table · Quva Pharma, Inc. Sugar Land, TX
    Form FDA 483 (linked from FDA's registration table)
    Source
  42. FMD-145 letter Matched · SKNV formerly registered as Sincerus Florida, LLC Pompano Beach, FL
    FMD-145 Letter Issued 04/22/2026
    No document link published
  43. Form FDA 483 FDA table · BPI Labs LLC Largo, FL
    Form FDA 483 (linked from FDA's registration table)
    Source
  44. Form FDA 483 Matched · Wells Pharma of Houston, LLC Houston, TX
    Amended 483 Issued 04/14/2026 (PDF - 1.44 MB)
    Source
  45. Form FDA 483 FDA table · Wells Pharma of Houston, LLC Houston, TX
    Form FDA 483 (linked from FDA's registration table)
    Source
  46. Form FDA 483 FDA table · Wells Pharmacy, Inc. Dyersburg, TN
    Form FDA 483 (linked from FDA's registration table)
    Source
  47. FMD-145 letter Matched · Molecular PharmaGroup New Providence, NJ
    FMD-145 Letter Issued 04/8/2026
    No document link published
  48. Warning letter FDA table · ProRx LLC Exton, PA
    Warning Letter Issued 4/7/2026
    Source
  49. FMD-145 letter Uncertain match · IntegraDose Compounding Services, LLC Shoreview, MN
    FMD-145 Letter Issued 3/26/2026
    No document link published
  50. FMD-145 letter Uncertain match · IntegraDose Compounding Services, LLC Shoreview, MN
    FMD-145 Letter Issued 3/25/2026
    No document link published
  51. Warning letter close-out Uncertain match · Tailstorm Health Inc. Chandler, AZ
    Warning Letter Close Out Issued 03/23/2026
    Source
  52. Recall Matched · Fagron Compounding Services dba Fagron Sterile Services Wichita, KS
    Class II recall, 5 product line(s): Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
    Source
  53. Warning letter Matched · RC Outsourcing, LLC Lowellville, OH
    Warning Letter (03/20/2026)
    Source
  54. FMD-145 letter Uncertain match · Tailstorm Health Inc. Chandler, AZ
    FMD-145 Letter Issued 03/20/2026
    No document link published
  55. FMD-145 letter Uncertain match · Tailstorm Health Inc. Chandler, AZ
    FMD-145 Letter Issued 03/19/2026
    No document link published
  56. Form FDA 483 FDA table · SCA Pharmaceuticals Windsor, CT
    Form FDA 483 (linked from FDA's registration table)
    Source
  57. Form FDA 483 FDA table · BayCare Integrated Service Center, LLC dba BayCare Central Pharmacy Temple Terrace, FL
    Form FDA 483 (linked from FDA's registration table)
    Source
  58. Regulatory meeting FDA table · BSO LLC Lakewood, CO
    Regulatory Meeting Held 3/3/2026
    No document link published
  59. Regulatory meeting FDA table · Fagron Compounding Services dba Fagron Sterile Services Wichita, KS
    Regulatory Meeting Held 2/27/2026
    No document link published
  60. Form FDA 483 FDA table · Staska Pharmaceuticals, Inc. Bennet, NE
    Form FDA 483 (linked from FDA's registration table)
    Source
  61. Recall Matched · Fresenius Kabi Compounding LLC dba Fagron Sterile Services Canton, MA
    Class II recall, 5 product line(s): Lack of Assurance of Sterility
    Source
  62. Untitled letter FDA table · Molecular PharmaGroup New Providence, NJ
    Untitled Letter Issued 2/5/2026; document link from FDA's compounding actions page ("Untitled Letter Issued 02/05/2026 (PDF - 858 KB)")
    Source
  63. Warning letter Matched · Apollo Care Columbia, MO
    Warning Letter (02/02/2026)
    Source
  64. Warning letter Uncertain match · GenoGenix LLC Raton, FL
    Warning Letter (01/20/2026)
    Source
  65. Form FDA 483 FDA table · US Specialty Formulations LLC Allentown, PA
    Form FDA 483 (linked from FDA's registration table)
    Source
  66. FMD-145 letter Matched · Wedgewood Connect, LLC, formerly registered as Leiter's Compounding San Jose, CA
    FMD-145 Letter Issued 01/02/2026
    No document link published
  67. Form FDA 483 FDA table · F.H. Investments, Inc. Birmingham, AL
    Form FDA 483 (linked from FDA's registration table)
    Source
  68. Recall Matched · Imprimis NJOF, LLC Ledgewood, NJ
    Class II recall, 3 product line(s): Presence of particulate matter - Glass like particles.
    Source
  69. Warning letter FDA table · MedisourceRx Los Alamitos, CA
    Warning Letter Issued 12/12/2025
    Source
  70. Form FDA 483 FDA table · Denver Solutions, LLC, dba Leiters Health Englewood, CO
    Form FDA 483 (linked from FDA's registration table)
    Source
  71. Form FDA 483 FDA table · Nubratori, Inc. Torrance, CA
    Form FDA 483 (linked from FDA's registration table)
    Source
  72. Warning letter Matched · Apothecary Pharma, LLC Cary, NC
    Warning Letter Issued 12/01/2025
    Source
  73. Form FDA 483 FDA table · Delta Pharma, Inc. Ripley, MS
    Form FDA 483 (linked from FDA's registration table)
    Source
  74. Untitled letter Matched · Leesar Inc. Fort Myers, FL
    Untitled Letter issued 11/21/2025
    Source
  75. Recall Matched · Fagron Compounding Services dba Fagron Sterile Services Wichita, KS
    Class II recall, 1 product line(s): Incorrect Product Formulation
    Source
  76. Form FDA 483 FDA table · Empower Pharma Houston, TX
    Form FDA 483 (linked from FDA's registration table)
    Source
  77. Form FDA 483 FDA table · OSRX, Inc. Missoula, MT
    Form FDA 483 (linked from FDA's registration table)
    Source
  78. Form FDA 483 FDA table · Pine Pharmaceuticals, LLC Tonawanda, NY
    Form FDA 483 (linked from FDA's registration table)
    Source
  79. Form FDA 483 Uncertain match · Tailstorm Health Inc. Chandler, AZ
    483 Issued 11/14/2025
    Source
  80. Warning letter Matched · Wells Pharma of Houston, LLC Houston, TX
    Warning Letter Issued 11/07/2025
    Source
  81. Form FDA 483 FDA table · Fresenius Kabi Compounding LLC dba Fagron Sterile Services Canton, MA
    Form FDA 483 (linked from FDA's registration table)
    Source
  82. Form FDA 483 FDA table · SCA Pharmaceuticals Little Rock, AR
    Form FDA 483 (linked from FDA's registration table)
    Source
  83. Recall Matched · Imprimis NJOF, LLC Ledgewood, NJ
    Class III recall, 1 product line(s): Subpotent Drug
    Source
  84. Recall Matched · ProRx LLC Exton, PA
    Class II recall, 7 product line(s): Lack of Assurance of Sterility
    Source
  85. Recall Matched · Farmakeio Outsourcing LLC Southlake, TX
    Class II recall, 15 product line(s): CGMP Deviations: Potential presence of metal particulate matter
    Source
  86. Warning letter Matched · PQ Pharmacy LLC Brooksville, FL
    Warning Letter (10/10/2025)
    Source
  87. Recall Matched · Quva Pharma, Inc. Sugar Land, TX
    Class II recall, 1 product line(s): Presence of Particulate Matter
    Source
  88. Recall Matched · STAQ Pharma, Inc. Denver, CO
    Class III recall, 3 product line(s): Labeling: Incorrect or Missing Lot and/or Exp Date
    Source
  89. Form FDA 483 FDA table · Park Avenue Compounding St. Louis, MO
    Form FDA 483 (linked from FDA's registration table)
    Source
  90. Recall Matched · Park Avenue Compounding St. Louis, MO
    Class II recall, 1 product line(s): CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
    Source
  91. Recall Matched · RC Outsourcing, LLC Lowellville, OH
    Class II recall, 1 product line(s): Lack of assurance of sterility.
    Source
  92. Form FDA 483 FDA table · ProRx LLC Exton, PA
    Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page ("483 Issued 09/19/2025")
    Source
  93. Recall Matched · Park Avenue Compounding St. Louis, MO
    Class II recall, 1 product line(s): CGMP Deviations
    Source
  94. Recall Uncertain match · IntegraDose Compounding Services, LLC Shoreview, MN
    Class I recall, 1 product line(s): Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
    Source
  95. Untitled letter Matched · SKNV formerly registered as Sincerus Florida, LLC Pompano Beach, FL
    Untitled Letter Issued 09/16/2025
    Source
  96. Warning letter Matched · Turbare Manufacturing Conway, AR
    Warning Letter (09/16/2025)
    Source
  97. Form FDA 483 FDA table · Central Admixture Pharmacy Services, Inc. Allentown, PA
    Form FDA 483 (linked from FDA's registration table)
    Source
  98. Form FDA 483 FDA table · Central Admixture Pharmacy Services Phoenix, AZ
    Form FDA 483 (linked from FDA's registration table)
    Source
  99. Form FDA 483 FDA table · Farmakeio Outsourcing LLC Southlake, TX
    Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page ("483 Issued 09/05/2025")
    Source
  100. Form FDA 483 FDA table · Qualgen LLC Edmond, OK
    Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page ("483 Issued 09/04/2025 (PDF - 1.78MB)")
    Source
  101. Recall Matched · Fagron Compounding Services dba Fagron Sterile Services Wichita, KS
    Class II recall, 1 product line(s): Lack of Assurance of Sterility
    Source
  102. Form FDA 483 Matched · RC Outsourcing, LLC Lowellville, OH
    483 Issued 08/28/2025
    Source
  103. Form FDA 483 FDA table · Nephron Sterile Compounding Center, LLC (NSCC) West Columbia, SC
    Form FDA 483 (linked from FDA's registration table)
    Source
  104. Form FDA 483 FDA table · Molecular PharmaGroup New Providence, NJ
    Form FDA 483 (linked from FDA's registration table)
    Source
  105. Form FDA 483 FDA table · AnazaoHealth Corporation Las Vegas, NV
    Form FDA 483 (linked from FDA's registration table)
    Source
  106. Form FDA 483 FDA table · Fagron Compounding Services dba Fagron Sterile Services Wichita, KS
    Form FDA 483 (linked from FDA's registration table)
    Source
  107. Form FDA 483 Uncertain match · Olympia Pharmaceuticals Orlando, FL
    Amended 483 Issued 08/08/2025 (PDF - 928 KB)
    Source
  108. Recall Uncertain match · GenoGenix LLC Raton, FL
    Class I, Class II recall, 57 product line(s): Lack of Assurance of Sterility
    Source
  109. FMD-145 letter Matched · Delta Pharma, Inc. Ripley, MS
    FMD-145 Letter Issued 07/29/2025
    No document link published
  110. FMD-145 letter Matched · BPI Labs LLC Largo, FL
    FMD-145 Letter Issued 07/28/2025
    No document link published
  111. Form FDA 483 Uncertain match · IntegraDose Compounding Services, LLC Shoreview, MN
    483 issued 07/25/2025 (PDF - 1,243 KB)
    Source
  112. Form FDA 483 FDA table · GenoGenix LLC Raton, FL
    Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page ("Amended 483 Issued 07/18/2025 (PDF - 4.7MB)"). That listing is an uncertain match: Name and state match; city listed as 'Boca Raton' vs 'Raton' in FDA's registration table
    Source
  113. Form FDA 483 FDA table · Right Value Drug Stores, LLC, dba Carie Boyd's Prescription Shop Irving, TX
    Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page ("483 Issued 07/18/2025 (PDF - 1.60MB)"). That listing is an uncertain match: Name and state match but a different city (Hurst, TX); may be another site of the same company
    Source
  114. Form FDA 483 Uncertain match · BSO LLC Golden, CO
    Amended 483 Issued 07/16/2025 (PDF - 3 MB)
    Source
  115. Form FDA 483 FDA table · BSO LLC Lakewood, CO
    Form FDA 483 (linked from FDA's registration table)
    Source
  116. Recall Matched · Imprimis NJOF, LLC Ledgewood, NJ
    Class II, Class III recall, 2 product line(s): Sub-Potent Drug: Subpotent assay results during stability testing.
    Source
  117. Form FDA 483 FDA table · Wedgewood Connect, LLC, formerly registered as Leiter's Compounding San Jose, CA
    Form FDA 483 (linked from FDA's registration table)
    Source
  118. Form FDA 483 FDA table · BSO LLC Golden, CO
    Form FDA 483 (linked from FDA's registration table)
    Source
  119. Form FDA 483 Uncertain match · BSO LLC Lakewood, CO
    483 Issued 06/27/2025 (PDF - 2 MB)
    Source
  120. FMD-145 letter Matched · OurPharma LLC Fayetteville, AR
    FMD-145 Letter Issued 06/23/2025
    No document link published
  121. Untitled letter Matched · Quva Pharma, Inc. Sugar Land, TX
    Untitled Letter Issued 06/18/2025
    Source
  122. Recall Matched · Qualgen LLC Edmond, OK
    Class III recall, 1 product line(s): Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
    Source
  123. Form FDA 483 FDA table · MedisourceRx Los Alamitos, CA
    Form FDA 483 (linked from FDA's registration table)
    Source
  124. Form FDA 483 FDA table · Medi-Fare Drug Blacksburg, SC
    Form FDA 483 (linked from FDA's registration table)
    Source
  125. FMD-145 letter Matched · STAQ Pharma, Inc. Denver, CO
    FMD-145 Letter Issued 06/06/2025
    No document link published
  126. Recall Uncertain match · Tailstorm Health Inc. Chandler, AZ
    Class II recall, 6 product line(s): Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
    Source
  127. Form FDA 483 FDA table · Stokes Healthcare Inc., dba Epicur Pharma Mt. Laurel, NJ
    Form FDA 483 (linked from FDA's registration table)
    Source
  128. Form FDA 483 Matched · Tailstorm Health Inc. Chandler, AZ
    483 Issued 05/23/2025 (PDF - 1.27 MB)
    Source
  129. Form FDA 483 Matched · Apothecary Pharma, LLC Cary, NC
    483 Issued 05/15/2025
    Source
  130. Form FDA 483 Matched · Leesar Inc. Fort Myers, FL
    483 Issued 05/09/2025 (PDF - 854KB)
    Source
  131. FMD-145 letter Matched · F.H. Investments, Inc. Birmingham, AL
    FMD-145 Letter Issued 05/08/2025
    No document link published
  132. Warning letter Matched · Staska Pharmaceuticals, Inc. Bennet, NE
    Warning Letter (05/05/2025)
    Source
  133. Recall Uncertain match · BSO LLC Golden, CO
    Class II recall, 5 product line(s): Presence of Particulate Matter: Glass particles were found in pellet vials.
    Source
  134. Recall Matched · BSO LLC Lakewood, CO
    Class II recall, 5 product line(s): Presence of Particulate Matter: Glass particles were found in pellet vials.
    Source
  135. Warning letter Matched · OSRX, Inc. Missoula, MT
    Warning Letter Issued 04/23/2025
    Source
  136. FMD-145 letter Matched · SCA Pharmaceuticals Windsor, CT
    FMD-145 Letter Issued 04/17/2025
    No document link published
  137. Recall Matched · Apollo Care Columbia, MO
    Class II recall, 1 product line(s): Lack of Assurance of Sterility
    Source
  138. Recall Matched · Nubratori, Inc. Torrance, CA
    Class II recall, 1 product line(s): Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the oute
    Source
  139. Recall Matched · OurPharma LLC Fayetteville, AR
    Class III recall, 1 product line(s): Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
    Source
  140. Warning letter Uncertain match · Tailstorm Health Inc. Chandler, AZ
    Warning Letter Issued 04/08/2025
    Source
  141. Form FDA 483 Matched · PQ Pharmacy LLC Brooksville, FL
    483 issued 04/04/2025 (PDF - 1.82 MB)
    Source
  142. Form FDA 483 FDA table · Quva Pharma, Inc. Bloomsbury, NJ
    Form FDA 483 (linked from FDA's registration table)
    Source
  143. Warning letter Uncertain match · Empower Pharma Houston, TX
    Warning Letter Issued 04/02/2025
    Source
  144. Recall Matched · Denver Solutions, LLC, dba Leiters Health Englewood, CO
    Class II recall, 5 product line(s): Lack of Assurance of Sterility: Leaking/damaged syringes.
    Source
  145. Form FDA 483 Matched · Wells Pharma of Houston, LLC Houston, TX
    483 issued 03/28/2025 (PDF - 2.72MB)
    Source
  146. Form FDA 483 Matched · Apollo Care Columbia, MO
    483 Issued 03/27/2025 (PDF - 2 MB)
    Source
  147. Recall Matched · Quva Pharma, Inc. Sugar Land, TX
    Class II recall, 3 product line(s): Lack of Assurance of Sterility
    Source
  148. Form FDA 483 Matched · SKNV formerly registered as Sincerus Florida, LLC Pompano Beach, FL
    483 Issued 03/06/2025 (PDF - 698KB)
    Source
  149. Warning letter Matched · Annovex Pharma, Inc. Lorton, VA
    Warning Letter Issued 03/05/2025
    Source
  150. Warning letter Matched · ProRx LLC Exton, PA
    Amended Warning Letter Issued 03/04/2025
    Source
  151. Recall Matched · Imprimis NJOF, LLC Ledgewood, NJ
    Class III recall, 1 product line(s): Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
    Source
  152. Form FDA 483 Matched · BPI Labs LLC Largo, FL
    483 Issued 02/21/2025 (PDF - 338 KB)
    Source
  153. Recall Matched · Central Admixture Pharmacy Services, Inc. Allentown, PA
    Class I recall, 1 product line(s): Presence of Particulate Matter
    Source
  154. Recall Matched · Turbare Manufacturing Conway, AR
    Class II recall, 1 product line(s): Lack of Assurance of Sterility: due to a quality control process deviation
    Source
  155. FMD-145 letter Matched · Brookfield Medical/Surgical Supply, Inc. Brookfield, CT
    FMD-145 Letter Issued 02/13/2025
    No document link published
  156. Recall Matched · Nephron Sterile Compounding Center, LLC (NSCC) West Columbia, SC
    Class II recall, 1 product line(s): Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
    Source
  157. Recall Matched · Fagron Compounding Services dba Fagron Sterile Services Wichita, KS
    Class II recall, 1 product line(s): Lack of Assurance of Sterility
    Source
  158. Form FDA 483 Matched · Turbare Manufacturing Conway, AR
    483 Issued 01/24/2025 (PDF - 1.37MB)
    Source
  159. Warning letter Matched · Nubratori, Inc. Torrance, CA
    Warning Letter Issued 01/22/2025
    Source
  160. Form FDA 483 Matched · SCA Pharmaceuticals Windsor, CT
    483 Issued 12/20/2024 (PDF - 2.45 MB)
    Source
  161. Warning letter Matched · Fagron Compounding Services dba Fagron Sterile Services Wichita, KS
    Warning Letter (12/19/2024)
    Source
  162. Warning letter Uncertain match · Right Value Drug Stores, LLC, dba Carie Boyd's Prescription Shop Irving, TX
    Warning Letter Issued 12/17/2024
    Source
  163. FMD-145 letter Matched · Denver Solutions, LLC, dba Leiters Health Englewood, CO
    FMD-145 Letter Issued 11/20/2024
    No document link published
  164. Form FDA 483 Matched · F.H. Investments, Inc. Birmingham, AL
    483 Issued 11/08/2024 (PDF - 1.91MB)
    Source
  165. Recall Uncertain match · Tailstorm Health Inc. Chandler, AZ
    Class II recall, 1 product line(s): Lack of Sterility Assurance
    Source
  166. Form FDA 483 Matched · Quva Pharma, Inc. Sugar Land, TX
    483 Issued 10/28/2024 (PDF - 1.75MB)
    Source
  167. Form FDA 483 Matched · OSRX, Inc. Missoula, MT
    483 Issued 10/25/2024 (PDF - 1.45MB)
    Source

Newly registered in the last 12 months (initial registration date)

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