FDA EIR - STERITECH, INC. - February 10, 2021

The FDA conducted a compliance follow-up inspection of STERITECH, INC., a contract sterilizer of Class II and Class III medical devices located in Salinas, PR, from February 3 to February 10, 2021. This inspection, a QSIT Level 1 assessment, focused on the company’s Corrective and Preventive Actions (CAPA) and Production and Process Controls systems, under the regulatory framework for medical device manufacturers. The inspection identified three significant observations, documented on an FDA-483 form. Firstly, the company lacked adequately established procedures for corrective and preventive actions, as evidenced by a valve change performed outside the formal CAPA system without effectiveness verification, and a failure to open a CAPA for recurring temperature issues in equipment. Secondly, documentation for corrective and preventive action activities was insufficient, with a CAPA closed without verifying the effectiveness of new biological indicator handling procedures, and previous CAPAs addressing prior inspection findings also lacking documented effectiveness checks based on consultant advice. Lastly, production processes were not consistently monitored to ensure device specifications were met, with multiple temperature deviations identified days after their occurrence during batch record review, rather than in real-time. Management, represented by Mr. Jorge Vivoni, acknowledged these issues and committed to implementing corrections. Required actions include updating various operational, quality, and training procedures, reinforcing good documentation practices through retraining, and conducting retrospective reviews of process parameters. The company is also performing an equivalence study for a replaced valve. STERITECH, INC. has a target completion date of March 31, 2021, for these corrective measures.