FDA Inspection
Saginaw Medical Service IncSaginaw Medical Service Inc – FDA Inspection, May 10, 2017
Record Details
This FDA Inspection record concerns Saginaw Medical Service Inc, with an inspection on May 10, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Cynthia L. Aycock (Issuing Officer)
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ID · 05657c83-bb17-4779-bec3-82ba648aacfe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1013040
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.20(e)Quality System Procedures
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