FDA Inspection
American Quality Manufacturing, Inc.American Quality Manufacturing, Inc. – FDA Inspection, Mar 29, 2011
Record Details
This FDA Inspection record concerns American Quality Manufacturing, Inc., with an inspection on March 29, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 29, 2011
- Product Type
- Devices
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ID · b8158a13-289a-4b3d-be1c-c29ff455b1c7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 716355
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 1040.20(c)(2)(iii)Timer interval error - greater than 10 percent
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 1002.13Failure to submit
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Other FDA inspections of American Quality Manufacturing, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 10, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for American Quality Manufacturing, Inc.
- FDA Inspection 763019 - 2012-01-10
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