FDA Inspection
Franklin Respiratory and Medical, Inc.Franklin Respiratory and Medical, Inc. – FDA Inspection, Mar 6, 2014
Record Details
This FDA Inspection record concerns Franklin Respiratory and Medical, Inc., with an inspection on March 6, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 6, 2014
- Product Type
- Drugs
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ID · ac6fedd9-6c4e-4885-853f-d830f1aa20ab
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 869589
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.82(b)Quarantine Storage of Components
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Franklin Respiratory and Medical, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 28, 2011 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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