Company
United StatesBiocare Systems, Inc., Parker, CO – FDA Inspections
Inspection records and compliance data for Biocare Systems, Inc. in Parker, Colorado. 3 FDA inspections on record, 1 Form 483, last inspected October 31, 2017.
Company Profile
This profile covers Biocare Systems, Inc. based in Parker, Colorado, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected December 3, 2010. Last inspected October 31, 2017.
Most cited issue areas
- Design validation - software validation not performed1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 31, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1030316 |
| October 24, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 853027 |
| December 3, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 701319 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Biocare Systems, Inc.
FEI Number
3005510978
Address
10940 S Parker Rd Pmb 107, Parker, Colorado 80134, United States
Country
United States
ID: f65c9250-a230-47b0-8968-8de5fa706712