Artesanales P.R. LLC – FDA 483, Oct 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.
ID · c688b633-7752-48db-8aac-82569a1bdb83
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