FDA Inspection 1000037 — King Pharmaceuticals LLC
The FDA completed an inspection of King Pharmaceuticals LLC on Nov 21, 2016 in Rochester, MI. 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
- Nov 21, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rochester, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |