Warning letter
Rite-Kem Incorporated: warning letter of Jan 28, 2025
FDA warning letter 697272 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 697272 |
|---|---|
| Company | Rite-Kem Incorporated |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jan 28, 2025 |
| Posted date | Mar 18, 2025 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 211.22, 211.22(d), 211.25(a), 211.34, 211.67(a), 211.84(d)(1), 211.100(a), 211.165(a), 211.166(a), 211.188(b) |
| Inspection city | Tupelo |
| Inspection ZIP | 38801 |
| Inspection start date | Sep 9, 2024 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 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: