FDA Inspection
ConvaTec, IncConvaTec, Inc – FDA Inspection, Jul 1, 2010
Record Details
This FDA Inspection record concerns ConvaTec, Inc, with an inspection on July 1, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ConvaTec, Inc
- Inspection Date
- July 1, 2010
- Product Type
- Devices
View Company Profile
ID · 8590e5bf-190d-4d2b-9fe4-67d47b7eb03d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 670883
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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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 |
| 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 |
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 817170 - 2013-02-05
- FDA Inspection 716148 - 2011-03-23
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