FDA Inspection
Cork Medical ProductsCork Medical Products – FDA Inspection, Sep 15, 2015
Record Details
This FDA Inspection record concerns Cork Medical Products, with an inspection on September 15, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cork Medical Products
- Inspection Date
- September 15, 2015
- Product Type
- Devices
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ID · d0cb7a87-13e5-40ca-ad16-5829b93dcf5a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 943912
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.80(e)Documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184Lack of or inadequate DHR procedures
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