FDA Inspection
Pacific Precision Products, Inc.Pacific Precision Products, Inc. – FDA Inspection, Mar 9, 2015
Record Details
This FDA Inspection record concerns Pacific Precision Products, Inc., with an inspection on March 9, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 9, 2015
- Product Type
- Devices
View Company Profile
ID · 792d99fe-00c0-49e3-8b32-0b8fc634633f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 917113
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 803.17Lack of Written MDR Procedures
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