FDA Inspection
AssayPro LLCAssayPro LLC – FDA Inspection, Nov 5, 2015
Record Details
This FDA Inspection record concerns AssayPro LLC, with an inspection on November 5, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- AssayPro LLC
- Inspection Date
- November 5, 2015
- Product Type
- Devices
View Company Profile
ID · 9f5bd025-2370-481f-9eed-0f774043f05c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 946440
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 809.10(a)(2)Intended use
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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