FDA Inspection
Tricol Biomedical, Inc.Tricol Biomedical, Inc. – FDA Inspection, Apr 2, 2018
Record Details
This FDA Inspection record concerns Tricol Biomedical, Inc., with an inspection on April 2, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3eb827ef-805c-4ceb-a06e-2ad767c4977c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1047031
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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Other FDA inspections of Tricol Biomedical, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 18, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 11, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 2, 2009 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Tricol Biomedical, Inc.
- FDA Inspection 902739 - 2014-10-31
- FDA Inspection 858577 - 2013-12-18
- FDA Inspection 634610 - 2009-12-11
- FDA Inspection 635785 - 2009-12-02
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