FDA 483 - Artesanales P.R. LLC - January 22, 2025

Artesanales P.R. LLC in Bayamon, PR, received a Form 483 following a January 2025 inspection, citing a severe and repeated failure to establish a functional quality control unit. The firm failed to implement corrective actions from a previous inspection, leading to the manufacture and distribution of drug products without required laboratory release testing. This indicates a critical lack of adherence to cGMP regulations.