FDA 483 - BioMylz Pvt. Ltd. - February 07, 2020

An FDA inspection of BioMyz Pvt. Ltd. in Bangalore, India, from February 3-7, 2020, revealed extensive deficiencies across its drug manufacturing operations. The firm failed to establish and follow critical written procedures for quality control, production, equipment maintenance, and employee training. These issues indicate a systemic lack of adherence to current Good Manufacturing Practices (cGMP) regulations.