FDA Inspection 941497 — King Bio Inc.
The FDA completed an inspection of King Bio Inc. on September 4, 2015 in Asheville, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 4, 2015
- Fiscal Year
- 2015
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Asheville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1266 | 21 CFR 211.42(d) | Penicillin processing area not kept separate |
| 1409 | 21 CFR 211.42(c)(4) | In-Process Material Area |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1924 | 21 CFR 211.166(a)(5) | Testing of reconstituted drugs |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3551 | 21 CFR 211.46(d) | Penicillin air handling systems not kept separate |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4364 | 21 CFR 211.176 | Failing to test for penicillin cross-contamination |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |