FDA Inspection
Pentec HealthPentec Health – FDA Inspection, Apr 1, 2013
Record Details
This FDA Inspection record concerns Pentec Health, with an inspection on April 1, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pentec Health
- Inspection Date
- April 1, 2013
- Product Type
- Drugs
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ID · 8c8ebd43-241b-4af9-8925-bffa9bfcc76e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 826813
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(c)Sampling and testing plans not described
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.80(a)Procedures To Be in Writing
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Other FDA inspections of Pentec Health
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 8, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pentec Health
- FDA Inspection 1030994 - 2017-09-08
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