FDA 483 - Artesanales P.R. LLC - October 23, 2023

Artesanales P.R. LLC, a drug manufacturer in Bayamon, PR, was cited for significant deficiencies in its quality system and production controls. The inspection revealed a complete absence of a quality control unit, inadequate validation and stability programs, and failures in raw material identity testing. Additionally, the firm failed to investigate out-of-specification results and lacked proper documentation practices for batch records and yield calculations.