FDA 483 - Resilience US, Inc. - May 25, 2022

Amylin Ohio LLC, a sterile drug manufacturer in West Chester, OH, was cited for multiple significant deficiencies related to its Bydureon BCise injectable suspension product. Observations included issues with unqualified equipment, inadequate personnel training, insufficient investigation into batch failures, failure to reject non-conforming products, and non-adherence to written procedures. These findings indicate a lack of robust quality control and manufacturing process oversight.