FDA Inspection 747439 — Sirio Nutrition (California) LLC
The FDA completed an inspection of Sirio Nutrition (California) LLC on September 26, 2011 in City Of Industry, 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
- September 26, 2011
- Fiscal Year
- 2011
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- City Of Industry, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 15542 | 21 CFR 111.260(b) | Batch record - date, time; maintenance |
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15850 | 21 CFR 111.73 | Specifications met in-process purity, strength, composition |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |