FDA Inspection
Anetic Aid LtdAnetic Aid Ltd – FDA Inspection, Dec 12, 2017
Record Details
This FDA Inspection record concerns Anetic Aid Ltd, with an inspection on December 12, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · eb7f3e69-d310-45d0-a44e-edc7f4597038
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034749
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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