FDA Inspection
Mars Fishcare North America, Inc.Mars Fishcare North America, Inc. – FDA Inspection, Apr 7, 2023
Record Details
This FDA Inspection record concerns Mars Fishcare North America, Inc., with an inspection on April 7, 2023, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 02a2e597-8799-4b6e-8e74-7f771e1bd743
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1202153
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.63Equipment Design, Size and Location
Showing 10 of 12 citations.
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Other FDA inspections of Mars Fishcare North America, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 3, 2017 | OAI | Philadelphia District Office | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| May 5, 2014 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| August 22, 2011 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| December 18, 2008 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Mars Fishcare North America, Inc.
- FDA Inspection 1020188 - 2017-08-03
- FDA Inspection 876344 - 2014-05-05
- FDA Inspection 740993 - 2011-08-22
- FDA Inspection 553841 - 2008-12-18
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