FDA EIR - Future Pak LLC - January 11, 2018

An FDA surveillance inspection of Future Pak, Ltd., a contract drug packager, was conducted from January 8-11, 2018, at their Wixom, MI facility. This inspection focused on drug repackaging and relabeling operations, excluding dietary supplement manufacturing, and was performed according to CPGM 7356.002B. The inspection identified two significant observations, documented on an FDA Form 483, related to the company's quality system and equipment management. Firstly, the agency found that deviations from written production and process control procedures were not consistently recorded, citing 21 CFR 211.100(b). A specific instance highlighted an uncompleted preventative maintenance task that was not documented or investigated despite quality assurance review. Secondly, routine equipment calibration was not performed according to an adequate written program to ensure proper performance, citing 21 CFR 211.68(a). The firm lacked a defined program for calibrating critical equipment like magnahelic gauges, and these gauges were not tested post-service to confirm their accuracy during use. In response to these findings, Future Pak, Ltd. committed to providing a written response addressing the observations within 15 business days. No product samples were collected during the inspection.