FDA 483 - New England Compounding Pharmacy Inc., d/b/a New England Compounding Center - October 26, 2012

An FDA inspection of New England Compounding Pharmacy Inc., also known as New England Compounding Center, conducted from October 1 to October 26, 2012, revealed significant quality system deficiencies. Observations detailed on the Form FDA 483 highlighted critical issues in environmental controls and sterile processing practices for injectable products. The company failed to adequately investigate repeated microbial contamination found on personnel touch plates in Clean Room 1 and 2 production hoods between January and September 2012, with no identification of isolates, product impact assessments, or documented corrective actions. Furthermore, multiple autoclaves used for sterilizing bulk drug suspensions and equipment exhibited condensation, tarnished, and greenish discoloration on interior surfaces. Facility conditions included the proximity of a recycling facility generating airborne particulates near the HVAC system, and the presence of filamentous substances on HVAC returns, as well as yellow and greenish residues in clean room weigh station hoods. Other issues involved a leaking boiler with soiled floors near sterile prep areas, gaps in doors, and discolored, soiled surfaces on pass-throughs and tacky mats within critical controlled environments. These observations indicate a lack of control over conditions vital for ensuring the sterility and quality of compounded drugs, necessitating prompt corrective and preventive actions to meet regulatory expectations.