FDA Inspection 981579 — JE Rich Company
The FDA completed an inspection of JE Rich Company on Aug 18, 2016 in Ontario, CA. 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). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 18, 2016
- Fiscal Year
- 2016
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Ontario, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |