FDA Inspection 1085950 — Sterling Knight Pharmaceuticals, LLC
The FDA completed an inspection of Sterling Knight Pharmaceuticals, LLC on April 11, 2019 in Ripley, MS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 11, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ripley, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |