FDA EIR - Signal Medical Corporation - February 03, 2017

Signal Medical Corporation underwent an FDA inspection from January 23 to February 3, 2017, focusing on its medical device manufacturing operations in Marysville, MI. This compliance follow-up inspection was conducted under the Quality System Regulation (QSR) and relevant FDA guidance. The inspection identified significant issues, some of which were recurring from previous assessments.

The FDA issued a seven-item Form FDA 483, detailing key violations. These included the repeated failure to adequately validate the packaging design for sterile hip implant components and inadequacies in their Corrective and Preventive Action (CAPA) procedures. Specifically, the company had not identified the root cause for persistent rust-colored staining on porous-coated implants and failed to implement preventive actions despite trends in nonconforming products. A critical manufacturing process, specifically the (b)(4) process for removing impurities from implants, was found to be inadequately validated. Additionally, the company failed to properly review, evaluate, and investigate complaints, create records for all known complaints, and establish agreements with suppliers. A significant finding, previously discussed, was the failure to report a correction or removal of a device to the FDA.

Signal Medical Corporation's management acknowledged these observations and committed to correcting the issues, promising to submit a plan for corrective action to the Detroit District Office within fifteen business days.