FDA Inspection
Rx Compounding Inc.Rx Compounding Inc. – FDA Inspection, Aug 21, 2014
Record Details
This FDA Inspection record concerns Rx Compounding Inc., with an inspection on August 21, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Rx Compounding Inc.
- Inspection Date
- August 21, 2014
- Product Type
- Drugs
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ID · 1ec1b0fa-c7c4-497e-9625-04baa0fde6aa
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 892232
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of Rx Compounding Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 21, 2013 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Rx Compounding Inc.
- FDA Inspection 832980 - 2013-05-15
- FDA Inspection 823199 - 2013-03-21
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