FDA Inspection
Brewer Company, LLCBrewer Company, LLC – FDA Inspection, Jan 5, 2015
Record Details
This FDA Inspection record concerns Brewer Company, LLC, with an inspection on January 5, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Brewer Company, LLC
- Inspection Date
- January 5, 2015
- Product Type
- Devices
View Company Profile
ID · 91fa9d83-138d-4778-b7a6-a44a83b3ea6e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 909198
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.100(b)Documentation
- 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
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.30(g)Design validation - documentation
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Other FDA inspections of Brewer Company, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2025 | Not classified | Minneapolis District Office |
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