FDA 483 - Cantrell Drug Company - June 29, 2017

An FDA inspection of Cantrell Drug Company, an outsourcing facility, conducted from June 12-29, 2017, revealed significant regulatory violations. Key issues included a deficient quality control unit that failed to thoroughly investigate errors and inaccurate environmental and personnel monitoring plate enumerations. The company was observed discarding original documentation and routinely altering manufacturing records, indicating poor data integrity practices. Aseptic processing areas displayed critical deficiencies, such as persistent loss of positive differential pressures in cleanrooms and inadequate design with gaps around HEPA filters and cracks in ISO 5 hoods. These failures resulted in sterile products being manufactured and distributed under compromised conditions without proper investigation into product impact. The inspection also identified a lack of comprehensive investigations into environmental excursions, sterility testing abort events, and HEPA filter leaks. Cleaning and disinfection procedures were inadequate, with unapproved SOPs and incorrect disinfectant contact times, evidenced by the presence of various spore-forming bacteria. Furthermore, the firm lacked a written stability testing program, specifically for endotoxin levels throughout product shelf life, and its drug product labels were non-compliant, missing the required "This is a compounded drug" statement. Several observations were repeats from a previous inspection, underscoring a need for prompt and comprehensive corrective actions to address these serious concerns and ensure product quality and patient safety.