FDA 483 - Hopkinton Drug, Inc. - November 02, 2020

An FDA inspection of Hopkinton Drug, Inc., conducted from August 25 to November 2, 2020, revealed significant concerns regarding the facility's manufacturing environment and practices. The observations, documented in an FDA Form 483, suggest potential violations under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, which addresses conditions indicating products may be adulterated or prepared under insanitary conditions.

Key issues included non-microbial contamination within drug production areas. Thick white powder residues and blue staining were observed on equipment and surfaces in the hazardous drug room, where various hormone and controlled substance preparations are compounded. Similarly, flaking paint, rust, and yellow staining were noted on a balance used for non-hazardous products. Furthermore, inadequate maintenance of critical hoods, including non-adherence to manufacturer guidelines for filter changes, raised concerns about their effectiveness in preventing cross-contamination.

A major violation involved insufficient segregation and cleaning protocols for hazardous drugs. The firm utilized household cleaners without demonstrating their efficacy against pharmaceutical residues or hazardous materials. Critically, non-hazardous drug products, such as Naltrexone, were found to be improperly stored and processed within the hazardous drug production room, posing a significant risk of cross-contamination. Hopkinton Drug, Inc. is expected to promptly address these inspectional observations by implementing comprehensive corrective actions to ensure product quality, safety, and regulatory compliance.