Loading…
Amman Pharmaceutical Industries, a contract manufacturer of sterile over-the-counter and homeopathic drug products, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals during an FDA inspection in August 2023. The facility failed to maintain adequate aseptic processing controls, specifically lacking properly designed separate areas to prevent contamination and mix-ups, and relied on excessive manual interventions that compromised the protection of ISO 5 sterile environments. These manufacturing deficiencies rendered the firm's drug products adulterated under the Federal Food, Drug, and Cosmetic Act.