Company
United StatesConvaTec, Inc, Greensboro, NC – FDA Inspections
Inspection records and compliance data for ConvaTec, Inc in Greensboro, North Carolina. 6 FDA inspections on record (2 OAI), last inspected September 08, 2015.
Company Profile
This profile covers ConvaTec, Inc based in Greensboro, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 2
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected July 1, 2010. Last inspected September 8, 2015.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures3 inspections
- Report of Death or Serious Injury3 inspections
- Lack of or inadequate complaint procedures2 inspections
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 8, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 944337 |
| April 16, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 874758 |
| September 11, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 850595 |
| February 5, 2013 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 817170 |
| March 23, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 716148 |
| July 1, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 670883 |
FDA documents
EIRs (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
ConvaTec, Inc
FEI Number
3011987967
Address
7815 National Service Rd Ste 600, Greensboro, North Carolina 27409, United States
Country
United States
ID: d36901ec-8ef5-4adf-834f-d1ce66319584