Warning letter
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC: warning letter of Oct 21, 2022
FDA warning letter 644180 · Office of Pharmaceutical Quality Operations, Division II
Key facts
| Reference number | 644180 |
|---|---|
| Company | Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Oct 21, 2022 |
| Posted date | Nov 1, 2022 |
| Issuing office | Office of Pharmaceutical Quality Operations, Division II |
| Product type | Drugs |
| CFR sections cited | 201.115, 211.192, 211.194, 200.10(b), 211.42(c)(10)(iv), 211.165(b), 210.1(b), 211.180(a) |
| Inspection city | West Columbia |
| Inspection ZIP | 29172 |
| Inspection start date | Mar 28, 2022 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
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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: