FDA Inspection
Oregon Compounding Centers, Inc.Oregon Compounding Centers, Inc. – FDA Inspection, Aug 28, 2014
Record Details
This FDA Inspection record concerns Oregon Compounding Centers, Inc., with an inspection on August 28, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 28, 2014
- Product Type
- Drugs
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ID · 2eb15a1b-cf29-4ce7-aa82-d60bdbb5387c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 895788
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- 483 Response
FDA Citations
10- 21 CFR 211.166(b)Adequate number of batches on stability
- 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 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.192No written record of investigation
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