FDA Inspection 738197 — JE Rich Company
The FDA completed an inspection of JE Rich Company on Jul 19, 2011 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). 13 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 19, 2011
- Fiscal Year
- 2011
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Ontario, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1630 | 21 CFR 211.130(b) | Unlabeled filled containers controls |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2572 | 21 CFR 211.198(b) | Complaint File Location |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |