Warning letter
Sagent Pharmaceuticals, Inc.: warning letter of Jul 27, 2022
FDA warning letter 636636 · Division Pharmaceutical Quality Operations I
Key facts
| Reference number | 636636 |
|---|---|
| Company | Sagent Pharmaceuticals, Inc. |
| Subject | CGMP/Drugs/Adulterated |
| Issue date | Jul 27, 2022 |
| Posted date | Dec 20, 2022 |
| Issuing office | Division Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 211.63, 211.192, 200.10(b), 211.42(c)(10)(iii), 211.67(a), 211.42(c)(10)(iv), 210.1(b), 211.113(b), 211.94(b) |
| Inspection city | Plattsburgh |
| Inspection ZIP | 12903 |
| Inspection start date | Sep 21, 2021 |
| 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: