FDA Inspection
Unimed Surgical Products, Inc.FDA Inspection 746493 - Unimed Surgical Products, Inc. - September 21, 2011
Record Details
This FDA Inspection record concerns Unimed Surgical Products, Inc., with an inspection on September 21, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 21, 2011
- Product Type
- Devices
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ID · c7fab46d-a33b-44d9-af01-ca26e56517e5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 746493
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
11- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
Showing 10 of 11 citations.
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Other FDA inspections of Unimed Surgical Products, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 28, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 28, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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