FDA Inspection
AVITA MEDICAL AMERICAS LLCFDA Inspection 1246776 - AVITA MEDICAL AMERICAS LLC - August 07, 2024
Record Details
This FDA Inspection record concerns AVITA MEDICAL AMERICAS LLC, with an inspection on August 7, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cfe09086-3d54-4b60-8e66-205f3b9b492b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1246776
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(f)Design verification - documentation
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Other FDA inspections of AVITA MEDICAL AMERICAS LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for AVITA MEDICAL AMERICAS LLC
- FDA Inspection 1111181 - 2019-10-25
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