puget sound drug corporation – FDA Warning Letter, Mar 8, 2017

An FDA inspection of Puget Sound Drug Corporation dba Key Compounding Pharmacy from January 26 to March 8, 2017, revealed serious deficiencies in the production of sterile and non-sterile drug products, leading to adulterated drug products under section 501(a)(2)(A) of the FDCA. Violations included continued sterile drug production despite microbial contamination in ISO-5 and ISO-7 areas, inadequate cleaning and disinfecting procedures for aseptic processing, poor aseptic practices such as insufficient glove disinfection, and inadequate handling of hazardous drugs leading to potential cross-contamination. Additionally, aseptic practices for maintaining a suitable sterile environment were deficient, with observations like cardboard boxes and paper notes in cleanrooms. The firm's voluntary recall of sterile products and submitted corrective actions were reviewed, but many were deemed inadequate or lacked sufficient supporting documentation, with environmental samples still showing microbial growth. FDA strongly recommends a comprehensive assessment of operations, including aseptic processing, by a third-party consultant. The firm must respond within 15 working days with specific corrective steps and documentation to prevent legal action, including seizure and injunction.