FDA Inspection
Gresco Products, Inc.Gresco Products, Inc. – FDA Inspection, Jun 20, 2011
Record Details
This FDA Inspection record concerns Gresco Products, Inc., with an inspection on June 20, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Gresco Products, Inc.
- Inspection Date
- June 20, 2011
- Product Type
- Devices
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ID · f2b23c13-eb09-4fef-9154-83cbacdf6c9e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 726084
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.160(b)Distribution records
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
Showing 10 of 12 citations.
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Other FDA inspections of Gresco Products, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 7, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 10, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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