FDA Inspection 1017462 — Sincerus Florida, LLC dba SKNV
The FDA completed an inspection of Sincerus Florida, LLC dba SKNV on June 26, 2017 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
- June 26, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pompano Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 18008 | FDCA 503B(a)(10) | Drug product label, outsourcer facility |