FDA Inspection
Unimed Surgical Products, Inc.FDA Inspection 610007 - Unimed Surgical Products, Inc. - August 28, 2009
Record Details
This FDA Inspection record concerns Unimed Surgical Products, Inc., with an inspection on August 28, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 28, 2009
- Product Type
- Devices
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ID · eae8dd09-d768-4130-9ebc-3079edadd2cd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 610007
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
13- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(c)Incomplete, ambiguous, conflicting design requirements
- 21 CFR 820.25(b)Training records
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(a)(1)Process control instructions
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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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 |
| September 21, 2011 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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