Company
United StatesBioteque America, Inc., San Jose, CA – FDA Inspections
Inspection records and compliance data for Bioteque America, Inc. in San Jose, California. 2 FDA inspections on record, last inspected July 15, 2013.
Company Profile
This profile covers Bioteque America, Inc. based in San Jose, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected June 24, 2011. Last inspected July 15, 2013.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Lack of or inadequate complaint procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 15, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 840273 |
| June 24, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 732112 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bioteque America, Inc.
FEI Number
1000121341
Address
2051 Junction Ave Ste 128, San Jose, California 95131, United States
Country
United States
ID: 886f7066-b209-4519-b7d7-430006aa13b3