FDA Inspection
PROXIMAGEN LLCPROXIMAGEN LLC – FDA Inspection, Mar 5, 2019
Record Details
This FDA Inspection record concerns PROXIMAGEN LLC, with an inspection on March 5, 2019, issued by the Minneapolis District Office, covering human drugs.
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ID · f5f44dbe-801e-4a9f-a6c3-c44872ea4d08
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1081434
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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