FDA Inspection
Med-Pharmex, Inc.Med-Pharmex, Inc. – FDA Inspection, Jan 11, 2018
Record Details
This FDA Inspection record concerns Med-Pharmex, Inc., with an inspection on January 11, 2018, issued by the Los Angeles District Office, covering animal drugs & feeds.
- People
- Carrie A. Hughes (Issuing Officer)
- Mai X. Huynh (Issuing Officer)
- Nicholas L. Hunt (FDA Associated Person)
- Robert D. Tollefsen (Company Rep)
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ID · feb1e071-5dda-42fa-9c3c-0ca108059302
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1037677
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
22- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.110(b)In-process conformity - examination, sample testing
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.142(a)Quarantine - actual practice
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(3)Drug products - samples representative, identified properly
- 21 CFR 211.160(b)(3)Drug products-sampling procedures/specifications
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
Showing 10 of 22 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 |
| 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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