FDA Inspection
AURORA TECHNOLOGY PTE LTDAURORA TECHNOLOGY PTE LTD – FDA Inspection, Mar 28, 2024
Record Details
This FDA Inspection record concerns AURORA TECHNOLOGY PTE LTD, with an inspection on March 28, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bd98270f-f66e-4d55-b055-eddf2662ac56
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1235859
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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