FDA Inspection
AgroChem USA, LLCFDA Inspection 871561 - AgroChem USA, LLC - March 31, 2014
Record Details
This FDA Inspection record concerns AgroChem USA, LLC, with an inspection on March 31, 2014, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- AgroChem USA, LLC
- Inspection Date
- March 31, 2014
- Product Type
- Veterinary
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ID · e085fe54-bd4a-4941-a626-dbbc91473d5a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 871561
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
13- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.34Consultant Records
- 21 CFR 211.165(c)Sampling and testing plans not described
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(a)Procedures To Be in Writing
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Other FDA inspections of AgroChem USA, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 13, 2023 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| October 25, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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