Medegen Medical Racks Up 13-Item Form 483 for Numerous Quality System Failures

A January inspection of Gallaway, Tennessee-based device manufacturer Medegen Medical Products by the FDA uncovered a range of quality system failures, including a serious lack of process controls for which the firm received a 13-item Form 483.

The firm’s injection molding process used to produce medical devices was not validated, nor was the sterilization process for sterile products.

The investigator observed that process control procedures “that describe any process controls necessary to ensure conformance to specifications have not been adequately established.”

For example, the firm used “untitled and uncontrolled documents as a guide for setting up injection molders” and to manufacture three-gallon sharps containers, the agency said.