FDA Inspection
ERGO FLEX Technologies LLCERGO FLEX Technologies LLC – FDA Inspection, Apr 10, 2017
Record Details
This FDA Inspection record concerns ERGO FLEX Technologies LLC, with an inspection on April 10, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 10531d1a-253c-4fe2-bbf5-b9bfcabe4dae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1022655
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
19- 21 CFR 820.80(e)Documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
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