FDA Inspection
Practica Medical Manufacturing, IncPractica Medical Manufacturing, Inc – FDA Inspection, Nov 19, 2015
Record Details
This FDA Inspection record concerns Practica Medical Manufacturing, Inc, with an inspection on November 19, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 19, 2015
- Product Type
- Devices
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ID · 7ef2d99e-f862-4e57-8615-849ec4b8c08f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 949804
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
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