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

Hopkinton Drug, Inc., a producer of non-sterile drug products in Hopkinton, MA, was cited for significant deficiencies during an FDA inspection. Observations included widespread non-microbial contamination in production areas, such as residues, staining, and facility degradation. The firm also failed to adequately segregate hazardous drug production, clean work surfaces, and maintain utensils, leading to cross-contamination risks.