FDA Inspection
ConvaTec, IncConvaTec, Inc – FDA Inspection, Apr 16, 2014
Record Details
This FDA Inspection record concerns ConvaTec, Inc, with an inspection on April 16, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ConvaTec, Inc
- Inspection Date
- April 16, 2014
- Product Type
- Devices
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ID · a06aa07e-f5ea-4341-989c-182d14a9e9da
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 874758
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint 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 |
| September 11, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 5, 2013 | OAI | 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 850595 - 2013-09-11
- FDA Inspection 817170 - 2013-02-05
- FDA Inspection 716148 - 2011-03-23
- FDA Inspection 670883 - 2010-07-01
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