FDA Inspection
AJ Medical Manufacturing L.L.C.AJ Medical Manufacturing L.L.C. – FDA Inspection, Mar 7, 2017
Record Details
This FDA Inspection record concerns AJ Medical Manufacturing L.L.C., with an inspection on March 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 936b33f7-8f2b-4857-9966-520a7076c1a5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1021110
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
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