FDA Inspection 741721 — San-J International, Inc.
The FDA completed an inspection of San-J International, Inc. on September 7, 2011 in Henrico, VA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 8 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 7, 2011
- Fiscal Year
- 2011
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Henrico, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1090 | 21 CFR 110.40(d) | Holding, conveying, mfg systems - design & construction |
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 1422 | 21 CFR 110.20(b)(4) | Floors, walls and ceilings |
| 1560 | 21 CFR 110.35(c) | Lack of effective pest exclusion |
| 3075 | 21 CFR 114.80(a)(4) | Container testing |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |
| 3089 | 21 CFR 114.100(c) | Process deviations- identification and records |
| 4475 | 21 CFR 108.25(c)(3)(i) | Process adherence |