Company
United StatesBiocare Medical, LLC, Pacheco, CA – FDA Inspections
Inspection records and compliance data for Biocare Medical, LLC in Pacheco, California. 2 FDA inspections on record, last inspected January 11, 2016.
Company Profile
This profile covers Biocare Medical, LLC based in Pacheco, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected April 27, 2015. Last inspected January 11, 2016.
Most cited issue areas
- Lack of or inadequate organizational structure1 inspection
- Lack of or inadequate procedures1 inspection
- Report of risk to health1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 11, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 961525 |
| April 27, 2015 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 923342 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Biocare Medical, LLC
FEI Number
3004140393
Address
60 Berry Dr, Pacheco, California 94553, United States
Country
United States
ID: c6e7122a-0282-4f07-8ea5-2a6528b44ea9