FDA Inspection 1263272 — SKNV
The FDA completed an inspection of SKNV on Mar 6, 2025 in Pompano Beach, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 6, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pompano Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 22733 | FDCA 501(a)(2)(A) | Beta-lactam, hazardous, highly potent drugs, prevention of cross-contamination |
| 22789 | FDCA 503B(a)(10)(B) | Drug product container, fails to include |