FDA Inspection
American Contract Systems, Inc.American Contract Systems, Inc. – FDA Inspection, Sep 14, 2009
Record Details
This FDA Inspection record concerns American Contract Systems, Inc., with an inspection on September 14, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 14, 2009
- Product Type
- Devices
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ID · 1419da28-6b9f-4d36-bc55-ab3fb9ccf479
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 606539
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)General
- 21 CFR 820.70(a)(2)Production monitoring and control
- 21 CFR 820.80(d)Quarantine of finished devices
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of American Contract Systems, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 11, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 3, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for American Contract Systems, Inc.
- FDA Inspection 1026492 - 2017-05-11
- FDA Inspection 873839 - 2014-04-03
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