Loading…
Bio-Medical Pharmaceutical Manufacturing Corporation was found to be manufacturing adulterated over-the-counter drugs due to significant violations of Current Good Manufacturing Practice (CGMP) regulations during an FDA inspection in August 2025. The facility failed to establish proper written procedures to prevent microbiological contamination of sterile drug products, including inadequate validation of aseptic and sterilization processes, and lacked separate or defined areas with appropriate controls to prevent contamination in aseptic processing areas. Additionally, the company failed to fulfill its drug listing obligations under federal regulations, a violation prohibited under the FD&C Act.