FDA Inspection 752843 — Ceva Animal Health
The FDA completed an inspection of Ceva Animal Health on Nov 4, 2011 in Oldsmar, 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). 12 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 4, 2011
- Fiscal Year
- 2012
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Oldsmar, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1725 | 21 CFR 211.134(c) | Examinations documented |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4327 | 21 CFR 211.122(c) | Records fail to include |
| 4386 | 21 CFR 211.198(b) | Written complaint record to be maintained at facility |
| 4388 | 21 CFR 211.198(a) | Complaints reviewed by Quality Control Unit |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |