Neilmed Pharmaceuticals Inc – FDA 483, Dec 2, 2022

Neilmed Pharmaceuticals Inc. in Santa Rosa, CA, a drug manufacturer, was cited for significant quality control deficiencies during an FDA inspection. Observations included a lack of a functional quality control unit, inadequate complaint investigations, improper equipment cleaning and verification, and insufficient testing of raw materials and finished drug products. The firm also failed to document production deviations and ensure proper storage conditions for materials.