FDA 483 - Biocon Generics Inc. - February 02, 2022

EYWA PHARMA INC, a pharmaceutical drug manufacturer in Cranbury, NJ, was cited for significant deficiencies during an FDA inspection from January 24 to February 2, 2022. Observations included inadequate investigations into out-of-specification results, failure to conduct risk assessments for process changes, and a lack of proper cleaning validation and procedures for manufacturing equipment. These issues indicate a systemic breakdown in quality control and adherence to good manufacturing practices.