FDA Inspection
Anetic Aid Ltd.Anetic Aid Ltd. – FDA Inspection, Dec 14, 2017
Record Details
This FDA Inspection record concerns Anetic Aid Ltd., with an inspection on December 14, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 27ef4886-d1c5-4f53-805e-5882e4a1df38
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034888
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
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