FDA 483 - Buckeye International Inc - August 21, 2025

Buckeye International Inc. in Maryland Heights, MO, was inspected and cited for significant deficiencies in its drug manufacturing processes. The inspection revealed failures in component identity verification, laboratory controls, process validation, stability testing, and facility maintenance, indicating a systemic lack of adherence to quality standards. These issues collectively raise concerns about the identity, strength, purity, and quality of the drug products manufactured.