FDA Inspection
ConvaTec, IncConvaTec, Inc – FDA Inspection, Feb 5, 2013
Record Details
This FDA Inspection record concerns ConvaTec, Inc, with an inspection on February 5, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ConvaTec, Inc
- Inspection Date
- February 5, 2013
- Product Type
- Devices
View Company Profile
ID · c624b162-b4ff-4120-a957-9708edf792a2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 817170
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ConvaTec, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 8, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 16, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 11, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 23, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 1, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ConvaTec, Inc
- FDA Inspection 944337 - 2015-09-08
- FDA Inspection 874758 - 2014-04-16
- FDA Inspection 850595 - 2013-09-11
- FDA Inspection 716148 - 2011-03-23
- FDA Inspection 670883 - 2010-07-01
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