Warning letter
Fagron Compounding Services LLC dba Fagron Sterile Services: warning letter of Nov 28, 2017
FDA warning letter 537637 · Detroit District Office
Key facts
| Reference number | 537637 |
|---|---|
| Company | Fagron Compounding Services LLC dba Fagron Sterile Services |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Nov 28, 2017 |
| Posted date | Nov 28, 2017 |
| Issuing office | Detroit District Office |
| Product type | Drugs |
| CFR sections cited | 211.22(d), 210.1(b), 211.192, 200.10(b), 211.165(a) |
| Inspection city | Wichita |
| Inspection ZIP | 67226 |
| Inspection start date | Aug 29, 2016 |
| 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: