Canadian Devicemakers Get FDA Warning Letters for GMP, Marketing Issues

Two devicemakers in Mississauga, Ontario, recently received FDA Warning Letters, with Techlem Medical cited for quality issues and Trexo Robotics Holdings for marketing unapproved products.

Techlem Medical manufactures wheeled stretchers in facilities that do not meet the FDA’s GMP requirements, the agency wrote following a June 19-22, 2023, inspection. During that inspection, the investigator’s observations included:

• Failure to establish procedures for implementing corrective and preventive action
• No established procedures for quality audits
• Failure to establish and maintain a design history file for each type of device
• Failure to establish quality requirements for suppliers, contractors and consultants
• Failure to establish procedures to control document changes

During an inspection of Trexo Robotics June 3-5, 2023, an FDA investigator found that devices made by the company do not have an approved PMA or IDE.

Read the Techlem Medical Warning Letter here.

Read the Trexo Robotics Warning Letter here.

To read the whole story, click here.

Related Topics