503B Docket

Quva Pharma, Inc. 503B outsourcing facility · Sugar Land, TX

This is a record of what FDA published, not a rating. Last FDA inspection and Form 483 status below are as published in FDA's registered outsourcing facilities table (as of Sep 30, 2026).

FDA registration record

Listed by FDA asQuva Pharma, Inc., Sugar Land, TX
City / stateSugar Land, TX
FDA's table lists city and state only, not a street address.
Contact phone (as listed by FDA)1-832-500-7450
Initial registration date9/10/2015
Most recent registration date12/2/2025
Outsourcing facilities must re-register annually (Oct 1 – Dec 31) to remain on FDA's list.
Last inspection (FDA table)5/4/2026
Form 483 issued at last inspection?Yes · View Form 483 (FDA PDF)
Recall conducted? (FDA table)No
Action based on last inspectionOpen
“Open” means FDA has not determined whether further action will be taken (per FDA's table notes).
Intends to compound sterile drugs from bulk substancesYes
Self-reported by the facility at registration; FDA notes this information has not been verified by FDA.
Prior compounding inspection history flagYes
FDA footnotes this facility as the subject of at least one previous compounding inspection that resulted in a Form 483, warning letter or other action.

Source: FDA Registered Outsourcing Facilities

Published FDA records

4Form 483 records
0Warning letters
9Recall events (openFDA)
0Uncertain-match items

Counts include only items from FDA's table or exact name + city + state matches. They are counts of published records, not a score. Uncertain matches are shown below but not counted.

State board of pharmacy license lookup

Texas State Board of Pharmacy License Verification (license lookup)

Search the state board's lookup for this facility's license status and any disciplinary actions. We link to the state-level tool only and do not list license numbers. FDA's table does not include state board actions. Facilities that ship across state lines may also hold non-resident licenses in your state, so check your own state's board too.

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Timeline of FDA actions

Newest first. Sources: FDA's registration table, FDA's compounding actions page (2019 onward on the live page), and openFDA drug enforcement records. Items marked Uncertain match may relate to a different site or entity and are not counted. How matching works.

  1. Recall Matched
    Recall event 99311
    Class II · Ongoing · 1 product line(s) · Recall no. D-0664-2026
    Recalling firm as listed: QuVa Pharma, Inc., Sugar Land, TX. Reason: Failed Impurities/Degradation Specifications
    openFDA record · openFDA drug enforcement API
  2. FMD-145 letter Matched
    FMD-145 Letter Issued 05/05/2026
    Listed on FDA page under: QuVa Pharma, Inc. Sugar Land, TX - 503B Facility
    No document link published · FDA Compounding: Inspections, Recalls, and other Actions
  3. Inspection FDA table
    Last inspection per FDA table; Form 483 issued: Yes
    FDA document · FDA registered outsourcing facilities table
  4. Form FDA 483 FDA table
    Form FDA 483 (linked from FDA's registration table)
    FDA document · FDA registered outsourcing facilities table
  5. Recall Matched
    Recall event 97790
    Class II · Ongoing · 1 product line(s) · Recall no. D-0113-2026
    Recalling firm as listed: QuVa Pharma, Inc., Sugar Land, TX. Reason: Presence of Particulate Matter
    openFDA record · openFDA drug enforcement API
  6. Untitled letter Matched
    Untitled Letter Issued 06/18/2025
    Listed on FDA page under: QuVa Pharma, Inc. Sugar Land, TX - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  7. Recall Matched
    Recall event 96446
    Class II · Ongoing · 3 product line(s) · Recall no. D-0295-2025, D-0296-2025, D-0297-2025
    Recalling firm as listed: QuVa Pharma, Inc., Sugar Land, TX. Reason: Lack of Assurance of Sterility
    openFDA record · openFDA drug enforcement API
  8. Form FDA 483 Matched
    483 Issued 10/28/2024 (PDF - 1.75MB)
    Listed on FDA page under: QuVa Pharma, Inc. Sugar Land, TX - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  9. FMD-145 letter Matched
    FMD-145 Letter Issued 02/01/2023
    Listed on FDA page under: QuVa Pharma, Inc. Sugar Land, TX - 503B Facility
    No document link published · FDA Compounding: Inspections, Recalls, and other Actions
  10. FMD-145 letter Matched
    FMD-145 Letter Issued 01/24/2023
    Listed on FDA page under: QuVa Pharma, Inc. Sugar Land, TX - 503B Facility
    No document link published · FDA Compounding: Inspections, Recalls, and other Actions
  11. Form FDA 483 Matched
    483 Issued 08/18/2022 (PDF - 638KB)
    Listed on FDA page under: QuVa Pharma, Inc. Sugar Land, TX - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  12. Recall Matched
    Recall event 85773
    Class II · Terminated · 1 product line(s) · Recall no. D-1302-2020
    Recalling firm as listed: QuVa Pharma, Inc., Sugar Land, TX. Reason: Subpotent drug - Product did not contain drug.
    openFDA record · openFDA drug enforcement API
  13. Recall Matched
    Recall event 85547
    Class III · Terminated · 1 product line(s) · Recall no. D-1335-2020
    Recalling firm as listed: QuVa Pharma, Inc., Sugar Land, TX. Reason: Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
    openFDA record · openFDA drug enforcement API
  14. Recall Matched
    Recall event 84263
    Class II · Terminated · 27 product line(s) · Recall no. D-0546-2020, D-0547-2020, D-0548-2020, D-0549-2020, D-0550-2020, D-0551-2020 …
    Recalling firm as listed: QuVa Pharma, Inc., Sugar Land, TX. Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
    openFDA record · openFDA drug enforcement API
  15. Form FDA 483 Matched
    483 Issued 04/23/2019 (PDF - 693KB)
    Listed on FDA page under: QuVa Pharma, Inc. Sugar Land, TX - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  16. Recall Matched
    Recall event 81644
    Class III · Terminated · 1 product line(s) · Recall no. D-0295-2019
    Recalling firm as listed: QuVa Pharma, Inc., Sugar Land, TX. Reason: Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
    openFDA record · openFDA drug enforcement API
  17. Recall Matched
    Recall event 80980
    Class I · Terminated · 1 product line(s) · Recall no. D-0003-2019
    Recalling firm as listed: QuVa Pharma, Inc., Sugar Land, TX. Reason: Subpotent Drug: Product may not have the active ingredient present in the bag.
    openFDA record · openFDA drug enforcement API
  18. Recall Matched
    Recall event 73710
    Class I · Terminated · 1 product line(s) · Recall no. D-1066-2016
    Recalling firm as listed: QuVa Pharma, Inc., Sugar Land, TX. Reason: Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe.
    openFDA record · openFDA drug enforcement API