FDA Inspection
American Contract Systems IncAmerican Contract Systems Inc – FDA Inspection, Aug 14, 2024
Record Details
This FDA Inspection record concerns American Contract Systems Inc, with an inspection on August 14, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 32ee493b-6359-4e17-84fc-9d3200fdd5ac
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1246895
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of American Contract Systems Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 2, 2025 | OAI | Cincinnati District Office | Compliance: Medical Devices |
| April 27, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 22, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 14, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for American Contract Systems Inc
- FDA Inspection 1271788 - 2025-06-02
- FDA Inspection 1011028 - 2017-04-27
- FDA Inspection 754154 - 2011-11-22
- FDA Inspection 705754 - 2011-01-14
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