FDA Inspection
ConvaTec LimitedConvaTec Limited – FDA Inspection, Feb 9, 2017
Record Details
This FDA Inspection record concerns ConvaTec Limited, with an inspection on February 9, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2f199aab-bea3-4778-a848-2b7c1bd53cf6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1007024
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.198(c)Investigation of device failures
- 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 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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