FDA Inspection
Performance Modalities, Inc.Performance Modalities, Inc. – FDA Inspection, Apr 2, 2009
Record Details
This FDA Inspection record concerns Performance Modalities, Inc., with an inspection on April 2, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Performance Modalities, Inc.
- Inspection Date
- April 2, 2009
- Product Type
- Drugs
View Company Profile
ID · 9e6f17a2-f32a-47f4-a4a7-95137fd1283f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 578789
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 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 211.125(f)Procedures Written and Followed
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Performance Modalities, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 19, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Performance Modalities, Inc.
- FDA Inspection 698508 - 2010-11-19
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