FDA Inspection
The Garmon CorporationThe Garmon Corporation – FDA Inspection, Aug 22, 2019
Record Details
This FDA Inspection record concerns The Garmon Corporation, with an inspection on August 22, 2019, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 464b8ea6-cbb7-49db-9501-ce724d403d55
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100176
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.198(a)Adverse Drug Experience
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of The Garmon Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2023 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| February 1, 2018 | Not classified | Los Angeles District Office | |
| December 1, 2016 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| April 5, 2010 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| August 19, 2009 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for The Garmon Corporation
- FDA Inspection 1222839 - 2023-11-06
- FDA Inspection 1042032 - 2018-02-01
- FDA Inspection 997573 - 2016-12-01
- FDA Inspection 654478 - 2010-04-05
- FDA Inspection 608358 - 2009-08-19
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