Warning letter
Fagron Compounding Services, LLC dba Fagron Sterile Service: warning letter of Dec 19, 2024
FDA warning letter 698861 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 698861 |
|---|---|
| Company | Fagron Compounding Services, LLC dba Fagron Sterile Service |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Dec 19, 2024 |
| Posted date | Feb 4, 2025 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 201.115, 211.192, 200.10(b), 211.56(a), 211.113(b), 210.1(b) |
| Inspection city | Wichita |
| Inspection ZIP | 67226 |
| Inspection start date | Jun 18, 2024 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: