FDA Inspection
American Contract Systems, Inc.American Contract Systems, Inc. – FDA Inspection, Apr 12, 2017
Record Details
This FDA Inspection record concerns American Contract Systems, Inc., with an inspection on April 12, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b76f4adb-849b-4e63-8d7c-a7ab6989d27e
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1021887
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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Other FDA inspections of American Contract Systems, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 4, 2019 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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