FDA Inspection
Painexx CorporationPainexx Corporation – FDA Inspection, Jun 18, 2009
Record Details
This FDA Inspection record concerns Painexx Corporation, with an inspection on June 18, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Painexx Corporation
- Inspection Date
- June 18, 2009
- Product Type
- Drugs
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ID · 7bdaa037-f15e-45fc-8268-c24cd945ad3a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 594105
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
17- 21 CFR 211.105(a)Identification of containers, lines, equipment
- 21 CFR 211.188(b)(3)Identification of each component or in-process material
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.186(b)(8)Description of containers, labels, et. al.
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.165(c)Sampling and testing plans not described
- 21 CFR 211.165(a)Testing and release for distribution
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Other FDA inspections of Painexx Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Painexx Corporation
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