FDA Inspection
MARIACHI OYMARIACHI OY – FDA Inspection, Apr 24, 2015
Record Details
This FDA Inspection record concerns MARIACHI OY, with an inspection on April 24, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MARIACHI OY
- Inspection Date
- April 24, 2015
- Product Type
- Devices
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ID · 30bebb41-3e45-4131-aaed-a4b5afffe99c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 927287
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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