FDA Inspection
Med-Pharmex, Inc.Med-Pharmex, Inc. – FDA Inspection, Jan 6, 2010
Record Details
This FDA Inspection record concerns Med-Pharmex, Inc., with an inspection on January 6, 2010, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Med-Pharmex, Inc.
- Inspection Date
- January 6, 2010
- Product Type
- Veterinary
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ID · a3f911e3-2b3e-4cf1-94e7-a697eb04fdf7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 640175
- FDA center
- Animal Drugs & Feeds
- Project area
- Pre-Approval Eval. of Animal Drugs and Food Additives
FDA Citations
12- 21 CFR 211.44Adequate lighting not provided
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.160(a)Lab controls established, including changes
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 |
| 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 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 |
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