FDA Inspection
3M Unitek Corporation3M Unitek Corporation – FDA Inspection, Mar 27, 2014
Record Details
This FDA Inspection record concerns 3M Unitek Corporation, with an inspection on March 27, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- 3M Unitek Corporation
- Inspection Date
- March 27, 2014
- Product Type
- Devices
View Company Profile
ID · f9a2c034-a20c-4a46-b4b7-7bb83aa86692
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 871900
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.40(b)Change records, content
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.72(b)Remedial action
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