FDA Inspection
AIM B.V.AIM B.V. – FDA Inspection, Mar 28, 2013
Record Details
This FDA Inspection record concerns AIM B.V., with an inspection on March 28, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- AIM B.V.
- Inspection Date
- March 28, 2013
- Product Type
- Devices
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ID · c7e9e6b9-cb2a-41ad-8a8c-42fada03cab4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 828765
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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