FDA Inspection
Micro-Mega SAMicro-Mega SA – FDA Inspection, Dec 7, 2017
Record Details
This FDA Inspection record concerns Micro-Mega SA, with an inspection on December 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · dad11910-c5ad-417d-97bd-97ad4e739096
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034461
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.50(a)(2)Supplier oversight
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