FDA Inspection 1083551 — CosMedical Technologies, LLC
The FDA completed an inspection of CosMedical Technologies, LLC on March 22, 2019 in Davie, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 22, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Davie, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |