FDA Inspection
Painexx CorporationPainexx Corporation – FDA Inspection, Nov 7, 2011
Record Details
This FDA Inspection record concerns Painexx Corporation, with an inspection on November 7, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Painexx Corporation
- Inspection Date
- November 7, 2011
- Product Type
- Drugs
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ID · d88f2748-12b0-440b-af4f-66b56941b35a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 753666
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.165(c)Sampling and testing plans not described
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of Painexx Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 18, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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