FDA EIR - STERITECH, INC. - February 19, 2019

An FDA inspection of STERITECH, INC., a contract sterilizer for medical devices located in Salinas, PR, was conducted from February 11 to February 19, 2019. The 'for cause' inspection focused on the company's quality system, specifically corrective and preventive actions (CAPA) and production and process controls, under regulations governing medical device manufacturers (21 CFR Part 820). The inspection revealed five significant observations. Firstly, production processes were not consistently executed to ensure devices met specifications, with issues noted in temperature monitoring and notification of affected products. Secondly, the company's procedures for corrective and preventive actions were found inadequate, as recurring issues often lacked proper trending analysis and corresponding CAPA initiation. Thirdly, documentation for CAPA activities was insufficient, with a specific instance showing a failure to verify the effectiveness of a corrective action. Fourthly, document control procedures were not adequately maintained, evident in missing information and improper documentation within log books and deviation reports. Lastly, certain measuring and test equipment was deemed unsuitable for its intended use, as the firm resorted to an unvalidated, temporary method for temperature monitoring during a primary system failure, without proper customer notification. In response to these findings, Mr. Jorge Vivoni, Vice President and General Manager, acknowledged all observations and committed to implementing corrective actions. Management was reminded of the importance of thorough investigations, timely customer communication, proactive trend analysis, and meticulous record-keeping to ensure ongoing compliance with federal regulations.