FDA EIR - Safecor Health, LLC - February 02, 2018

An FDA inspection of SAFECOR Health LLC, a drug repackager in Columbus, OH, was conducted from January 24 to February 2, 2018. This comprehensive surveillance inspection, carried out under regulatory guidelines for drug repackagers and relabelers and consistent with current Good Manufacturing Practice (cGMP) regulations, identified several significant issues. The primary violations, documented on an FDA Form 483, included the Quality Control Unit's failure to complete investigations within the required 45-day timeframe without documented extensions for incidents like CO 2017-8, CO 2017-9, and CO2017-10. Additionally, employees were observed not adhering to protective apparel requirements, specifically with exposed hair and earring jewelry in drug processing areas. The facility also lacked adequate mirrors in production and re-gowning areas to ensure employees properly wore hair restraints and other protective garments. Further verbal observations noted missing pest control records for two months in 2017, delays in reviewing Standard Operating Procedures (SOPs), inadequate line clearance procedures, and poor documentation practices in logbooks, with uncorrected write-overs. The firm was also advised to review its 12-month expiration dating policy for single-dose units in light of recent FDA draft guidance suggesting a shorter 6-month period unless supported by robust stability data. SAFECOR Health LLC management acknowledged these findings, making immediate corrections for some observations and committing to submit a written response to the FDA within 15 business days. They pledged to improve investigation timelines, update gowning procedures, install necessary mirrors, address pest control record-keeping, and enhance documentation practices.