GEM City Engineering Lacking in Controls, Device Acceptance Procedures

A litany of major GMP deficiencies — ranging from inadequate document control procedures, CAPA, device acceptance procedures and procedures to control product —  plagued GEM City Engineering and Manufacturing during a Feb. 21 to March 1 FDA inspection of its Dayton, Ohio facility.

The eight-item 483 cited numerous examples of the contract manufacturer’s faulty document control procedures. For example, document changes didn’t include a valid signature of the person approving the change, and procedures referenced documents that were not approved. The CMO’s supplier survey for its medical device metal supplier included a checklist that was not defined in the procedures, the 483 said.

Corrective and preventive action procedures were found lacking because none of the corrective action reports reviewed included a verification or validation prior to closing the corrective action reports.

A corrective action reported was initiated for deficiencies in process validation and included an action item to “write IQ, OQ, PQ procedures for our ISO 13485 Quality System.” However, the director of Quality and Continuous Improvement told the investigator there were no approved procedures for process validation “other than what is defined in their quality manual.”

At least 15 corrective action reports between May 2016 and October 2017 did not include any objective evidence or supporting documentation for corrective actions taken, the agency said.

The contract manufacturer failed to develop production processes that ensured devices conformed to specifications, and production procedures don’t define the manufacturing steps to assemble the SAF-T-Pump device, the FDA said. In addition, there were no procedures that defined acceptance criteria, including test methods for the device.

The FDA said that GEM City Engineering hadn’t documented complaints in the last two years, and it did not have procedures in place to adequately control nonconforming products. It also had not established procedures for device history records, and it did not document or approve the validation of the machines used in manufacturing medical devices.