FDA Inspection
J. Pohler Inc.J. Pohler Inc. – FDA Inspection, Dec 13, 2012
Record Details
This FDA Inspection record concerns J. Pohler Inc., with an inspection on December 13, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- J. Pohler Inc.
- Inspection Date
- December 13, 2012
- Product Type
- Devices
View Company Profile
ID · c76c7af8-72ac-4254-b0af-0a2b49e95ce6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 810445
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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