FDA 483 - NEOLPHARMA, INC. - June 07, 2017

Neolpharma, Inc. in Caguas, PR, a drug manufacturer, was cited for significant deficiencies during an FDA inspection. The firm failed to implement adequate controls to prevent objectionable microorganisms in manufacturing areas, with multiple instances of fungal and bacterial contamination. Additionally, the inspection revealed inadequate laboratory controls, including a lack of documented procedures for chromatographic data and insecure electronic data acquisition systems, raising concerns about data integrity.