FDA Inspection
Integrity Life Sciences, LLCIntegrity Life Sciences, LLC – FDA Inspection, Aug 1, 2012
Record Details
This FDA Inspection record concerns Integrity Life Sciences, LLC, with an inspection on August 1, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Integrity Life Sciences, LLC
- Inspection Date
- August 1, 2012
- Product Type
- Devices
View Company Profile
ID · bee60033-bc36-4b77-882a-fcd9277303ad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 793014
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.40(a)Document review, approval documentation
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