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.
Read the Medegen Medical Products Form 483 here: www.fdanews.com/05-22-18-medegenmedicalproductsllc483.pdf.
QSR-Compliant Equipment Control
Devicemakers must ensure that all equipment used in the manufacturing process meets specified requirements and that it is all appropriately designed, constructed, placed, installed, maintained, adjusted, cleaned and used.
Each of those steps warrants attention, from ensuring that outside suppliers provide equipment that is fit for purpose and meets regulatory requirements through placing and installing the equipment appropriately for its use and ensuring the equipment is regularly maintained, adjusted and cleaned in accordance with FDA expectations.
Under QSR, devicemakers’ responsibilities include:
QSR also requires devicemakers to determine if deviations from product specifications could occur in the manufacturing process and, if so, establish and maintain process control procedures to prevent that from happening. To ensure compliance, devicemakers must conduct periodic inspections of all production equipment.
21 CFR 820.70(g)(2) states: “Each manufacturer shall conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules. The inspections, including the date and individual(s) conducting the inspections, shall be documented.”
An important thing for devicemakers to keep in mind when developing and implementing these procedures is that they must define and document their own goals, as well as explaining step-by-step what is to be done and who is to do it. There should also be a method of follow-up to ensure that the procedures are actually followed.
Excerpted from the FDAnews management report: Three Phases of QSR-Compliant Equipment Control.