FDA Inspection
Oklahoma Respiratory Care, Inc.Oklahoma Respiratory Care, Inc. – FDA Inspection, Dec 18, 2012
Record Details
This FDA Inspection record concerns Oklahoma Respiratory Care, Inc., with an inspection on December 18, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 18, 2012
- Product Type
- Drugs
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ID · e8d93644-6f60-40a1-98df-22a63eef5ed5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 811098
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.196Distribution Record Requirements
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Oklahoma Respiratory Care, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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