FDA Inspection
BioCheck, Inc.BioCheck, Inc. – FDA Inspection, Jun 9, 2010
Record Details
This FDA Inspection record concerns BioCheck, Inc., with an inspection on June 9, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BioCheck, Inc.
- Inspection Date
- June 9, 2010
- Product Type
- Devices
View Company Profile
ID · 9051a2b0-a454-4c47-a5b2-585662568480
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 665791
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.30(g)Design validation - production units
Full citation text and observation details available on the Dashboard.
Other FDA inspections of BioCheck, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 7, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 19, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 12, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 17, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for BioCheck, Inc.
- FDA Inspection 1204769 - 2023-02-07
- FDA Inspection 1060644 - 2018-07-19
- FDA Inspection 904632 - 2014-12-12
- FDA Inspection 730360 - 2011-06-17
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