FDA Inspection
IMANIIMANI – FDA Inspection, Mar 22, 2023
Record Details
This FDA Inspection record concerns IMANI, with an inspection on March 22, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d0150101-457d-4893-85b7-1f505825fa16
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1200437
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.72(b)Remedial action - documentation
- 21 CFR 820.72(b)Remedial action - documentation
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