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FDA Inspection
•AVITA MEDICAL AMERICAS LLC•August 7, 2024

FDA 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.

Company
AVITA MEDICAL AMERICAS LLC
Inspection Date
August 7, 2024
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Kelvin Cheung (Issuing Officer)
View Company Profile

ID · 9fa3e8aa-2619-44f2-9f2a-ddc55ad29760

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1246776
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

FDA Citations

1
  1. 21 CFR 820.30(f)Design verification - documentation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of AVITA MEDICAL AMERICAS LLC

1
DateClassificationOfficeProject area
October 25, 2019NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for AVITA MEDICAL AMERICAS LLC
  • FDA Inspection 1111181 - 2019-10-25

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