503B Docket

Fagron Compounding Services dba Fagron Sterile Services 503B outsourcing facility · Wichita, KS

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 asFagron Compounding Services dba Fagron Sterile Services, Wichita, KS
City / stateWichita, KS
FDA's table lists city and state only, not a street address.
Contact phone (as listed by FDA)1-316-773-0405
Initial registration date10/2/2015
Most recent registration date11/21/2025
Outsourcing facilities must re-register annually (Oct 1 – Dec 31) to remain on FDA's list.
Last inspection (FDA table)8/8/2025
Form 483 issued at last inspection?483 · View Form 483 (FDA PDF)
Recall conducted? (FDA table)No
Action based on last inspectionRegulatory Meeting Held 2/27/2026
“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.

Source: FDA Registered Outsourcing Facilities

Published FDA records

4Form 483 records
1Warning letters
8Recall 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

Kansas State Board of Pharmacy (board site)

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 98636
    Class II · Ongoing · 5 product line(s) · Recall no. D-0438-2026, D-0439-2026, D-0440-2026, D-0441-2026, D-0442-2026
    Recalling firm as listed: Fagron Compounding Services, Wichita, KS. Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
    openFDA record · openFDA drug enforcement API
  2. Regulatory meeting FDA table
    Regulatory Meeting Held 2/27/2026
    No document link published · FDA registered outsourcing facilities table
  3. Recall Matched
    Recall event 98040
    Class II · Ongoing · 1 product line(s) · Recall no. D-0221-2026
    Recalling firm as listed: Fagron Compounding Services, Wichita, KS. Reason: Incorrect Product Formulation
    openFDA record · openFDA drug enforcement API
  4. Recall Matched
    Recall event 97540
    Class II · Ongoing · 1 product line(s) · Recall no. D-0646-2025
    Recalling firm as listed: Fagron Compounding Services, Wichita, KS. Reason: Lack of Assurance of Sterility
    openFDA record · openFDA drug enforcement API
  5. Inspection FDA table
    Last inspection per FDA table; Form 483 issued: 483
    FDA document · FDA registered outsourcing facilities table
  6. Form FDA 483 FDA table
    Form FDA 483 (linked from FDA's registration table)
    FDA document · FDA registered outsourcing facilities table
  7. Recall Matched
    Recall event 96232
    Class II · Completed · 1 product line(s) · Recall no. D-0225-2025
    Recalling firm as listed: Fagron Compounding Services, Wichita, KS. Reason: Lack of Assurance of Sterility
    openFDA record · openFDA drug enforcement API
  8. Warning letter Matched
    Warning Letter (12/19/2024)
    Listed on FDA page under: Fagron Compounding Services LLC (dba Fagron Sterile Services), Wichita, KS - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  9. Recall Matched
    Recall event 95146
    Class II · Ongoing · 1 product line(s) · Recall no. D-0636-2024
    Recalling firm as listed: Fagron Compounding Services, Wichita, KS. Reason: Lack of Assurance of Sterility
    openFDA record · openFDA drug enforcement API
  10. Form FDA 483 Matched
    483 Issued 06/28/2024 (PDF - 14 MB)
    Listed on FDA page under: Fagron Compounding Services LLC (dba Fagron Sterile Services), Wichita, KS - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  11. Recall Matched
    Recall event 93453
    Class III · Ongoing · 1 product line(s) · Recall no. D-0125-2024
    Recalling firm as listed: Fagron Compounding Services, Wichita, KS. Reason: Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
    openFDA record · openFDA drug enforcement API
  12. FMD-145 letter Matched
    FMD-145 Letter Issued 11/21/2022
    Listed on FDA page under: Fagron Compounding Services LLC (dba Fagron Sterile Services), Wichita, KS - 503B Facility
    No document link published · FDA Compounding: Inspections, Recalls, and other Actions
  13. Form FDA 483 Matched
    483 Issued 03/24/2022 (PDF - 7 MB)
    Listed on FDA page under: Fagron Compounding Services LLC (dba Fagron Sterile Services), Wichita, KS - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  14. Form FDA 483 Matched
    483 Issued 06/21/2019 (PDF - 2 MB)
    Listed on FDA page under: Fagron Compounding Services LLC (dba Fagron Sterile Services), Wichita, KS - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  15. Recall Matched
    Recall event 80383
    Class I · Terminated · 2 product line(s) · Recall no. D-0910-2018, D-0911-2018
    Recalling firm as listed: Fagron Compounding Services LLC dba Fagron Sterile Services, Wichita, KS. Reason: Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
    openFDA record · openFDA drug enforcement API
  16. Recall Matched
    Recall event 77584
    Class II · Terminated · 1 product line(s) · Recall no. D-0946-2017
    Recalling firm as listed: Fagron Compounding Services LLC dba Fagron Sterile Services, Wichita, KS. Reason: Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier
    openFDA record · openFDA drug enforcement API