FDA EIR - Liquipak Corp. - November 01, 2018

An FDA abbreviated surveillance inspection of Liquipak Corp., a contract repackager of topical OTC single-use drug packets, was conducted from October 31 to November 1, 2018, in Alma, MI. The inspection, carried out under regulatory guidelines for drug repackagers, evaluated the firm's quality system, facility, and equipment. The inspection resulted in a two-item FDA 483, Inspectional Observations. The primary violations included the quality control unit failing to fully adhere to its responsibilities and procedures. Specifically, the firm did not follow its established change control procedure, as a "Job Setup Specification" for packaging equipment was implemented without review and approval by the quality assurance unit. Additionally, the inspection found that routine inspections of mechanical equipment were not performed according to a written program designed to assure proper performance. This was evident in the firm's use of packaging machine #11 for a drug product without providing written documentation to demonstrate its equivalence to machine #12, on which process validations were performed. Two further discussion items were raised: the use of uncalibrated stopwatches for equipment setup monitoring and the failure to complete annual product reviews for a specific drug product. Management was cooperative and committed to providing a written response to the FDA 483 within 15 business days. They also indicated plans to implement annual product reviews and consider conducting new equipment qualification for machine #11.