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. “You have not established procedures that define the control of this process and during the inspection you stated that you routinely deviate from the parameters defined in the untitled document,” the agency said.
In addition, the facility lacked procedures for final acceptance testing, and a review of device history records indicated that products that did not meet specifications were accepted and there was no documentation when a nonconformance was later found.
None of the 16 complaint records reviewed included documentation that the complaint was evaluated for MDR reportability and none of the complaint records included documentation of an investigation or record of why no investigation was made.
The facility also lacked written MDR procedures and procedures were not adequately established to control product that did not conform to specified requirements. None of the non-conforming delivery or non-conforming material reports reviewed included documentation of an investigation or evaluation of whether an investigation was necessary, the agency said.
Rework and reevaluation activities were also not documented in the device history record, and CAPA procedures were inadequate.
The firm also failed to establish procedures for design changes or for evaluating suppliers or contractors, or to ensure sampling methods were adequate for their intended use.