FDA Inspection
Medibio USA LLCMedibio USA LLC – FDA Inspection, Apr 16, 2019
Record Details
This FDA Inspection record concerns Medibio USA LLC, with an inspection on April 16, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c7259c1c-008f-4543-9185-a64cb5b6831e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1086552
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 803.17Lack of Written MDR Procedures
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