Company
United StatesBioCheck, Inc., South San Francisco, CA – FDA Inspections
Inspection records and compliance data for BioCheck, Inc. in South San Francisco, California. 5 FDA inspections on record (1 OAI), last inspected February 07, 2023.
Company Profile
This profile covers BioCheck, Inc. based in South San Francisco, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected June 9, 2010. Last inspected February 7, 2023.
Most cited issue areas
- Design history file1 inspection
- Design input - documentation1 inspection
- Design validation - production units1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 7, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1204769 |
| July 19, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1060644 |
| December 12, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 904632 |
| June 17, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 730360 |
| June 9, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 665791 |
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
BioCheck, Inc.
FEI Number
3002564473
Address
425 Eccles Ave, South San Francisco, California 94080, United States
Country
United States
ID: 3c05ef75-fba1-42c8-b40b-24348534e385