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# QS and MDR Violations at OriGen Biomedical
- URL: https://www.fdaweb.com/qs-and-mdr-violations-at-origen-biomedical/
- Published: 2019-06-11T12:00:00.000Z
- Updated: 2026-09-15T01:31:54.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144306

A 6/11-7/5/18 FDA inspection at OriGen Biomedical, Austin, TX, for Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of dual lumen catheters, including the Reinforced Dual Lumen ECMO catheter. A just-released 12/20/18 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/origen-biomedical-inc-569074-12202018?ref=fdaweb.com) says specific violations were: 

- failing to establish procedures to control product that does not conform to specified requirements;
- failing to establish and maintain procedures to control all documents required by regulations;
- failing to report to FDA no later than 30 days after the firm received or otherwise became aware of information, from any source, reasonably suggesting that a device that it markets may have caused or contributed to a death or serious injury;
- failing to report to FDA no later than 30 days after the firm received or otherwise became aware of information, from any source, reasonably suggesting that a device the firm markets has malfunctioned and that device or a similar device that it markets would be likely to cause or contribute to a death or serious injury; and
- failing to adequately develop, maintain, and implement written MDR procedures.

The letter also says FDA determined that the company’s dual lumen catheters were misbranded due to the failure to furnish medical device reporting materials.

OriGen was told to take prompt action to correct the violations and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of each step and a timetable for implementation.