FDA 483 - BayCare Integrated Service Center LLC - December 10, 2019

During an FDA inspection conducted from November 18 to December 10, 2019, at BAYCARE INTEGRATED SERVICE CENTER, an outsourcing facility located in Temple Terrace, Florida, several significant quality control and manufacturing deficiencies were observed. The inspection revealed a consistent failure to thoroughly investigate unexplained discrepancies and out-of-specification results for drug products, including ephedrine sulfate and oxytocin batches. For instance, ephedrine lots showed inconsistent pH values and potency issues, yet comprehensive root cause analyses were not documented, and products were sometimes released without adequate investigation. Furthermore, the firm's quality control unit lacked written procedures for essential functions, such as qualifying suppliers and contract testing laboratories. Crucially, upper and lower pH specifications were not established for multiple sterile drug products, impacting identity, strength, quality, and purity. Environmental control also presented issues, with inadequate documentation and instruction for disinfectant use in controlled environments and improper orientation of air particle counters in aseptic processing areas. These observations highlight a need for BAYCARE INTEGRATED SERVICE CENTER to implement robust quality systems, including comprehensive investigation protocols, clear written procedures for quality unit responsibilities, established product specifications, and improved environmental monitoring practices to ensure compliance with regulatory standards for drug manufacturing.