FDA Inspection
Med-Pharmex, Inc.Med-Pharmex, Inc. – FDA Inspection, Feb 1, 2017
Record Details
This FDA Inspection record concerns Med-Pharmex, Inc., with an inspection on February 1, 2017, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · f8eb0028-4a17-405a-ba28-071d1623b556
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1000703
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 225.58(c)Assay results kept one year
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(a)Lab controls established, including changes
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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 |
| May 17, 2019 | 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 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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