FDA Inspection
Respa Pharmaceuticals Inc.Respa Pharmaceuticals Inc. – FDA Inspection, Aug 4, 2011
Record Details
This FDA Inspection record concerns Respa Pharmaceuticals Inc., with an inspection on August 4, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Respa Pharmaceuticals Inc.
- Inspection Date
- August 4, 2011
- Product Type
- Drugs
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ID · d8a2e091-4c0e-4cc9-ac3f-10434a0e05ba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 738390
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
FDA Citations
5- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.150Written distribution procedure
- 21 CFR 211.142(a)Quarantine - written procedures
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Other FDA inspections of Respa Pharmaceuticals Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 4, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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