GMP violations including failure to submit a premarket approval application for its denture liner and failure to register the device in 2015 prompted an FDA warning letter to Better Health Systems.
According to the April 7 letter, the company doesn’t have an approved PMA for its Bio-Soft Oraliner and didn’t notify FDA of its intent to introduce the device into commercial distribution.
During a December 10 to 12, 2014, inspection of BHS’ Monument, Colo., facility, FDA Denver district office investigators also found failures in process controls. For example, the company wasn’t able to provide instructions or procedures to determine and control the packaging and labeling of the device, the letter says.
The firm also was rapped for lacking procedures for maintaining lot history records to demonstrate that the device is manufactured in accordance with the master record, and for not implementing procedures for accepting or rejecting incoming products and documenting acceptance or rejection.
The FDA requires devicemakers to demonstrate that their products meet specified requirements, but BHS — which also develops specifications for Oraliner — had no documentation of inspections, tests or other verification of component shipments, the warning letter says.