Kings Park Slope Inc – FDA 483, Mar 14, 2014

An FDA inspection conducted at Kings Park Slope Inc., an outsourcing facility, on March 4-6 and 14, 2014, revealed significant deviations from regulatory expectations concerning sterile drug product manufacturing. The primary issues observed centered on the company's aseptic processing controls and quality assurance systems.

Specifically, the facility failed to adequately maintain equipment used to control aseptic conditions, evidenced by a lack of dynamic smoke studies to verify airflow, uncalibrated pressure gauges, and an obstructed cleanroom vent. Personnel gowning practices were found to be inappropriate, with operators wearing non-sterile attire that exposed skin and shed particles in critical sterile areas. Environmental monitoring was deficient, lacking daily viable air sampling, dynamic non-viable particulate testing, and routine microbial testing of surfaces and gloves. Furthermore, cleaning and disinfection procedures were inadequate, using non-sterile wipes and omitting sporicidal disinfectants for critical surfaces.

Crucially, the firm demonstrated a failure in ensuring product sterility, with limited sterility testing, no endotoxin testing data, and an absence of validated sterilization processes through media fills. Control over sterile components was also lacking, as certificates of analysis for sterility were not consistently obtained or reviewed for containers, closures, and purchased sterile equipment. To achieve compliance, Kings Park Slope Inc. must implement comprehensive corrective actions addressing these systemic deficiencies in environmental control, personnel practices, quality testing, and process validation to ensure the safety and sterility of its drug products.