FDA 483 - InvaGen Pharmaceuticals, Inc. - December 06, 2019

An FDA inspection of InvaGen Pharmaceuticals, Inc. in Hauppauge, NY, revealed significant deficiencies in drug manufacturing practices. Observations included inadequate review of analytical data prior to product release, failure to follow established in-process controls, and insufficient documentation of critical manufacturing steps. These issues indicate a lack of robust quality control and data integrity within the firm's operations.