FDA Inspection
Cooperative Workshops IncCooperative Workshops Inc – FDA Inspection, Jun 23, 2017
Record Details
This FDA Inspection record concerns Cooperative Workshops Inc, with an inspection on June 23, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · dd975f08-1fea-42a5-b95a-4a226fb20594
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015406
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Cooperative Workshops Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 1, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Cooperative Workshops Inc
- FDA Inspection 711756 - 2011-03-01
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