FDA Inspection 1274882 — CosMedical Technologies, LLC
The FDA completed an inspection of CosMedical Technologies, LLC on July 7, 2025 in Davie, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 7, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Davie, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1496 | 21 CFR 211.122(a) | Sampling/testing of labeling/packaging materials |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |