FDA Inspection 1229212 — SKNV
The FDA completed an inspection of SKNV on May 23, 2024 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 23, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pompano Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 21422 | FDCA 503B(b)(2)(A) | Outsourcing facility, compounded drug report follow up |
| 22789 | FDCA 503B(a)(10)(B) | Drug product container, fails to include |