FDA Inspection
JE Rich CompanyJE Rich Company – FDA Inspection, Aug 5, 2019
Record Details
This FDA Inspection record concerns JE Rich Company, with an inspection on August 5, 2019, issued by the Los Angeles District Office, covering animal drugs & feeds.
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ID · e337d738-b230-4c94-93b3-f9627424f110
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1099322
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.84(a)Components withheld from use pending release
Full citation text and observation details available on the Dashboard.
Other FDA inspections of JE Rich Company
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2018 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| July 2, 2018 | Not classified | Los Angeles District Office | |
| August 18, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| June 14, 2013 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| July 19, 2011 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for JE Rich Company
- FDA Inspection 1071670 - 2018-07-26
- FDA Inspection 1061467 - 2018-07-02
- FDA Inspection 981579 - 2016-08-18
- FDA Inspection 835335 - 2013-06-14
- FDA Inspection 738197 - 2011-07-19
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