FDA Inspection
American Contract Systems, Inc.American Contract Systems, Inc. – FDA Inspection, May 11, 2017
Record Details
This FDA Inspection record concerns American Contract Systems, Inc., with an inspection on May 11, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c06aa0f0-d648-4631-a1c3-3b386ea8650b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1026492
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
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Other FDA inspections of American Contract Systems, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 3, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 14, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for American Contract Systems, Inc.
- FDA Inspection 873839 - 2014-04-03
- FDA Inspection 606539 - 2009-09-14
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