GE Healthcare Technologies, Waukesha, WI, Feb. 22 (Cincinnati, OH).(MEDICAL DEVICES)

FDA found that the manufacturer of coils used in magnetic resonance imaging systems and breast biopsy plates was not in full conformance with current GMP requirements of the Quality Systems regulation.

The firm was cited for failure to assure that only those devices that are approved for release are distributed.

For example, it shipped product to customers prior to completion of the sterilization process validation, and shipped product to customers prior to verifying/validating the device design.

FDA noted that the response to this observation was incomplete. The preventive action listed in the response did not indicate how it would prevent devices with incomplete design validation from being released in the future.

Next, the firm did not document validation activities for breast biopsy plates. For example, for the previous contract sterilizer, there was no evidence of acceptance of revalidation activities since 2000.

Further, the firm failed to verify or validate corrective actions taken in response to CAPA 69 dated March 29, 2004. The firm identified soldering issues as one of the top three manufacturing defects. As part of the corrective action, it conducted off-site training in 2005 to improve solder skills. This was two-part training with a written exam and a hands-on practical test. Nine out of 17 (53%) of training records that FDA reviewed for solder skills were incomplete, missing, or showed failing results for that exam.

Also, the company did not investigate the possible failure of devices to meet any of their specifications when necessary.

For example, the firm did not document the investigation of complaint #13070082 received on March 3, 2006 involving knee coil early life failure, and there was no documentation of the investigation of this coil.

Further, the letter stated that the firm did not process its complaints in a uniform and timely manner.

For example, the current complaint procedure stated that PSRs (safety complaints) over 45 days and PQRs (quality reports) open over 90 days were overdue. The firm had at least 12 complaints that were beyond these time frames. Design; Val; C-H; CAPA; Doc. 14106W

Print Get the Mag Weekly Updates