FDA Inspection
TYRX Inc.TYRX Inc. – FDA Inspection, Feb 12, 2016
Record Details
This FDA Inspection record concerns TYRX Inc., with an inspection on February 12, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- TYRX Inc.
- Inspection Date
- February 12, 2016
- Product Type
- Devices
View Company Profile
ID · ce2d8f77-e365-4002-80bf-a65d5049b6f8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 968601
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.250(b)Sampling plans
Showing 10 of 11 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of TYRX Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2018 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 26, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 22, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for TYRX Inc.
- FDA Inspection 1042512 - 2018-02-27
- FDA Inspection 824116 - 2013-03-26
- FDA Inspection 668090 - 2010-06-22
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.