FDA 483 - Evaric Pharmaceuticals Inc. - May 16, 2025

Evaric Pharmaceuticals Inc. in Hauppauge, NY, received a Form 483 with four observations during an FDA inspection. The firm was cited for significant deficiencies in equipment cleaning validation and practices, as well as inadequate process validation. Additionally, issues were noted regarding material segregation and a lack of systems to ensure compliance with the Drug Supply Chain Security Act.