FDA 483 - NEOLPHARMA, INC. - February 05, 2019

Neopharma, Inc. in Caguas, PR, was inspected from January 24 to February 5, 2019, revealing a significant issue with procedures to prevent objectionable microorganisms in non-sterile drug products. The firm has experienced recurring microbiological deviations, even after implementing corrective and preventive actions stemming from a previous inspection. This indicates a persistent problem with microbial control within their manufacturing area.