FDA Inspection
TYRX Inc.TYRX Inc. – FDA Inspection, Feb 27, 2018
Record Details
This FDA Inspection record concerns TYRX Inc., with an inspection on February 27, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ea1f1df4-d856-46bd-bc46-d03657f650b3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1042512
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
Full citation text and observation details available on the Dashboard.
Other FDA inspections of TYRX Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2016 | 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 968601 - 2016-02-12
- FDA Inspection 824116 - 2013-03-26
- FDA Inspection 668090 - 2010-06-22
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