FDA Inspection
3m Canada Company3m Canada Company – FDA Inspection, Mar 19, 2015
Record Details
This FDA Inspection record concerns 3m Canada Company, with an inspection on March 19, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- 3m Canada Company
- Inspection Date
- March 19, 2015
- Product Type
- Devices
View Company Profile
ID · 020c0248-26c3-480c-beea-f85472a28277
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 920404
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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