Warning letter
Nephron SC Inc.: warning letter of Oct 11, 2022
FDA warning letter 634647 · Office of Pharmaceutical Quality Operations, Division II
Key facts
| Reference number | 634647 |
|---|---|
| Company | Nephron SC Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Oct 11, 2022 |
| Posted date | Oct 25, 2022 |
| Issuing office | Office of Pharmaceutical Quality Operations, Division II |
| Product type | Drugs |
| CFR sections cited | 314.81(b)(1)(ii), 210, 211.34, 211.192, 211.42(c)(10)(iv), 211.113(b), 314.81(b)(1), 314.81(b)(1)(i) |
| 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
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: