FDA Inspection
Med-Pharmex, Inc.Med-Pharmex, Inc. – FDA Inspection, May 17, 2019
Record Details
This FDA Inspection record concerns Med-Pharmex, Inc., with an inspection on May 17, 2019, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · bb114a04-b528-4f16-b59d-5cbffa201368
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1090363
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 514.80(b)(2)(i)Applicant did not submit/sent a late15-Day Initial alert report or wrong format
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(a)Approve or reject components, products
Showing 10 of 12 citations.
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Other FDA inspections of Med-Pharmex, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| December 18, 2023 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| January 11, 2018 | OAI | Los Angeles District Office | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| February 1, 2017 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| February 17, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| March 27, 2013 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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