FDA Inspection
Chek Lab, Inc.Chek Lab, Inc. – FDA Inspection, Nov 22, 2011
Record Details
This FDA Inspection record concerns Chek Lab, Inc., with an inspection on November 22, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Chek Lab, Inc.
- Inspection Date
- November 22, 2011
- Product Type
- Devices
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ID · d7e8c868-038b-4999-866f-21ee70d9e1f0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 753986
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(e)Quality System Procedures
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