FDA Inspection
Mars Fishcare North America, Inc.Mars Fishcare North America, Inc. – FDA Inspection, Aug 3, 2017
Record Details
This FDA Inspection record concerns Mars Fishcare North America, Inc., with an inspection on August 3, 2017, issued by the Philadelphia District Office, covering animal drugs & feeds.
- Inspection Date
- August 3, 2017
- Product Type
- Animal Drugs & Feeds
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ID · 8db86802-0805-43da-b184-2158c87f0181
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1020188
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.198(b)(3)Determination not to conduct investigation of complaint
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.63Equipment Design, Size and Location
Showing 10 of 13 citations.
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Other FDA inspections of Mars Fishcare North America, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 7, 2023 | VAI | Center for Veterinary Medicine | 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 1202153 - 2023-04-07
- FDA Inspection 876344 - 2014-05-05
- FDA Inspection 740993 - 2011-08-22
- FDA Inspection 553841 - 2008-12-18
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