FDA Inspection 831821 — Innovacyn Inc.
The FDA completed an inspection of Innovacyn Inc. on May 16, 2013 in Rialto, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 16, 2013
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Rialto, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |