FDA Inspection
American Contract Systems, Inc.American Contract Systems, Inc. – FDA Inspection, Oct 4, 2019
Record Details
This FDA Inspection record concerns American Contract Systems, Inc., with an inspection on October 4, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 4, 2019
- Product Type
- Devices
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ID · 69176171-bdc1-4ee6-9857-81e0a0d6ecad
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1105439
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.70(i)Software validation for automated processes
- 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.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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