FDA Inspection
Rx Compounding Inc.Rx Compounding Inc. – FDA Inspection, Mar 21, 2013
Record Details
This FDA Inspection record concerns Rx Compounding Inc., with an inspection on March 21, 2013, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Rx Compounding Inc.
- Inspection Date
- March 21, 2013
- Product Type
- Veterinary
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ID · 9c6a63cd-06d2-4507-bbd5-429e2b2574ef
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 823199
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
6- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Rx Compounding Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 15, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Rx Compounding Inc.
- FDA Inspection 892232 - 2014-08-21
- FDA Inspection 832980 - 2013-05-15
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