FDA 483 - Pharmaceutics International, Inc. - April 04, 2016

Pharmaceutics International, Inc. in Cockeysville, MD, was cited for multiple significant deficiencies during an FDA inspection from March 21 to April 4, 2016, primarily concerning sterile drug product manufacturing. Observations included failures in preventing microbiological contamination, inadequate equipment cleaning and maintenance, insufficient laboratory controls, and poor quality system adherence. These issues indicate a broad lack of adherence to cGMPs, posing potential risks to drug product quality and patient safety.