FDA Inspection
Gresco Products, Inc.Gresco Products, Inc. – FDA Inspection, Apr 7, 2015
Record Details
This FDA Inspection record concerns Gresco Products, Inc., with an inspection on April 7, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Gresco Products, Inc.
- Inspection Date
- April 7, 2015
- Product Type
- Devices
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ID · 3f5a1f87-0e90-4ec0-a8e0-cba79bf59e36
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 921450
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of Gresco Products, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 10, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 20, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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