FDA 483 - Resilience US, Inc. - August 09, 2019

Amylin Ohio LLC, a sterile drug manufacturer in West Chester, OH, was cited for three observations during an FDA inspection. The firm failed to adequately control and document rejected in-process materials, lacked proper disposition records for scrapped finished goods, and did not thoroughly investigate unexplained discrepancies and batch failures during packaging validation. These issues indicate deficiencies in material control, record-keeping, and quality system investigations.