FDA 483 - Bio-Medical Pharmaceutical Manufacturing Corporation - August 29, 2025

An FDA inspection of Bio-Medical Pharmaceutical Manufacturing Corporation in Houston, TX, revealed critical deficiencies in its OTC drug manufacturing operations. The firm failed to establish validated sterilization processes for an ophthalmic product, exhibited inadequate quality control oversight, and demonstrated widespread non-compliance in equipment cleaning, maintenance, and environmental controls. These issues indicate significant deviations from cGMP, raising concerns about the quality and safety of their drug products.