FDA Inspection
Copan ItaliaCopan Italia – FDA Inspection, Jan 17, 2012
Record Details
This FDA Inspection record concerns Copan Italia, with an inspection on January 17, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Copan Italia
- Inspection Date
- January 17, 2012
- Product Type
- Devices
View Company Profile
ID · 684ad1b8-eb77-468f-a5c5-99ca03a64f46
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 762943
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Copan Italia
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 14, 2018 | Not classified | Office of Inspections and Investigations | |
| September 27, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Copan Italia
- FDA Inspection 1047042 - 2018-03-14
- FDA Inspection 851822 - 2013-09-27
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