FDA Inspection
Actegy LimitedActegy Limited – FDA Inspection, Mar 8, 2018
Record Details
This FDA Inspection record concerns Actegy Limited, with an inspection on March 8, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · c0033ca1-2a78-4e61-84fa-0e73c5be6c96
Inspection Facts
- Inspection number
- 1043485
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(b)Rationale documented for no investigation
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