FDA Inspection 1210546 — Cosette Pharmaceuticals NC Laboratories, LLC
The FDA completed an inspection of Cosette Pharmaceuticals NC Laboratories, LLC on July 21, 2023 in Lincolnton, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 21, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lincolnton, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1251 | 21 CFR 211.42(c)(1) | Incoming material area |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |