FDA 483 - Park Avenue Compounding - August 28, 2019

An FDA inspection of SSM Health Care St. Louis DBA SSM St. Clare Health Center in Fenton, MO, an outsourcing facility, revealed significant deficiencies across multiple areas. The firm failed to establish and follow procedures to prevent microbiological contamination, maintain adequate environmental monitoring, and ensure proper quality control for sterile drug products. These issues indicate a systemic lack of adherence to current good manufacturing practices, posing a risk to product sterility and quality.