FDA Inspection
American Benchmark Machine Works, LLCAmerican Benchmark Machine Works, LLC – FDA Inspection, Sep 19, 2017
Record Details
This FDA Inspection record concerns American Benchmark Machine Works, LLC, with an inspection on September 19, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4d222fcc-3ebe-4e26-96d4-2caeb412bfbd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1026042
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of American Benchmark Machine Works, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 23, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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