Fagron Compounding Services LLC dba Fagron Sterile Services
FDA inspection history in Wichita, Kansas, 2016 to 2025
- 5
- Form 483s
- 2
- Warning letters
Every document, by year
- Form 483
- Warning letter
2016: one Form 483; 2017: one warning letter; 2019: one Form 483; 2022: one Form 483; 2024: one warning letter and one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–19Two Form 483s and one warning letter, at Wichita, Kansas.
- 2019The longest 483 on file: 11 observations over 8 pages at Wichita, Kansas.
- 2022–25Three Form 483s and one warning letter, at Wichita, Kansas.
Cited most
Across all Fagron Compounding Services LLC dba Fagron Sterile Services observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.165(a)Testing and release for distribution3
- 21 CFR 211.42(a)Design and construction features3
- 21 CFR 211.160General requirements2
The complete Fagron Compounding Services LLC dba Fagron Sterile Services file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Wichita, Kansas
Five Form 483s and two warning letters · 2016 to 2025 · 34 observations
Latest: Form 483, Aug 8, 2025 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-08-08 | 483 Form 483 | Wichita, Kansas | 6 | $99 |
| 2024-12-19 | Warning letter Warning letter | Wichita, Kansas | — | $99 |
| 2024-06-28 | 483 Form 483 | Wichita, Kansas | 7 | $99 |
| 2022-03-24 | 483 Form 483 | Wichita, Kansas | 6 | $99 |
| 2019-06-21 | 483 Form 483 | Wichita, Kansas | 11 | $99 |
| 2017-11-28 | Warning letter Warning letter | Wichita, Kansas | — | $99 |
| 2016-09-21 | 483 Form 483 | Wichita, Kansas | 4 | $99 |
Investigators on these documents
Alan M. Barker (1)Anthony Ladner (1)Brett R. Havranek (1)Erika V. Butler (1)Sean R. Marcsisin (1)Taichun Qin (1)
FEI number 3012104093 · most recent document Aug 8, 2025
About Fagron Compounding Services LLC dba Fagron Sterile Services
How many FDA Form 483s has Fagron Compounding Services LLC dba Fagron Sterile Services received?
FDA Intel has 5 Form 483s on file for Fagron Compounding Services LLC dba Fagron Sterile Services; the most recent is dated Aug 8, 2025.
When was Fagron Compounding Services LLC dba Fagron Sterile Services last inspected by FDA?
The most recent FDA inspection document on file for Fagron Compounding Services LLC dba Fagron Sterile Services is a Form 483 dated Aug 8, 2025, for the site in Wichita, Kansas.
What did FDA cite at Fagron Compounding Services LLC dba Fagron Sterile Services?
The regulations cited most in the observations on file for Fagron Compounding Services LLC dba Fagron Sterile Services are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.165(a) (Testing and release for distribution), 3 times.
Has Fagron Compounding Services LLC dba Fagron Sterile Services received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Fagron Compounding Services LLC dba Fagron Sterile Services; the most recent is dated Dec 19, 2024.