Warning letter
Genlabs Corporation: warning letter of May 12, 2022
FDA warning letter 625479 · Division of Pharmaceutical Quality Operations IV
Key facts
| Reference number | 625479 |
|---|---|
| Company | Genlabs Corporation |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | May 12, 2022 |
| Posted date | Jul 19, 2022 |
| Issuing office | Division of Pharmaceutical Quality Operations IV |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.67(b), 211.165(e), 201.66(d)(7), 211.165(a), 211.100(a), 211.22, 201.128 |
| Inspection city | Chino |
| Inspection ZIP | 91710 |
| Inspection start date | Nov 29, 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: