FDA Inspection 1263272 — Sincerus Florida, LLC dba SKNV
The FDA completed an inspection of Sincerus Florida, LLC dba SKNV on March 6, 2025 in Pompano Beach, 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 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 |