FDA Inspection 738907 — King Bio Inc.
The FDA completed an inspection of King Bio Inc. on Aug 10, 2011 in Asheville, NC. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 10, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Asheville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |