Warning letter
Sterling Pharmaceutical Services, LLC: warning letter of Sep 27, 2022
FDA warning letter 629019 · Division of Pharmaceutical Quality Operations III
Key facts
| Reference number | 629019 |
|---|---|
| Company | Sterling Pharmaceutical Services, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Sep 27, 2022 |
| Posted date | Oct 4, 2022 |
| Issuing office | Division of Pharmaceutical Quality Operations III |
| Product type | Drugs |
| CFR sections cited | 211.192, 211.42(c)(10)(iv), 211.113(b) |
| Inspection city | Dupo |
| Inspection ZIP | 62239 |
| Inspection start date | Feb 7, 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: