Warning letter
Brands International Corporation: warning letter of Dec 17, 2024
FDA warning letter 689983 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 689983 |
|---|---|
| Company | Brands International Corporation |
| Subject | CGMP/Finished Pharmaceutical/Adulterated/Refusal to Allow Inspection |
| Issue date | Dec 17, 2024 |
| Posted date | Dec 24, 2024 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 211.165(a), 211.22, 211.34, 211.137, 211.192, 211.42(b), 211.67(b), 211.84(d)(1), 211.100(a) |
| Inspection city | Newmarket |
| Inspection start date | Jun 17, 2024 |
| 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: