FDA 483 - Evaric Pharmaceuticals Inc. - March 01, 2021

Evaric Pharmaceuticals Inc. in Hauppauge, NY, was cited for significant deficiencies in its manufacturing processes and quality controls. Observations included a lack of written procedures for production and process controls, unqualified relocated equipment, and deficient batch production records with inconsistent documentation. Additionally, the firm failed to properly clean equipment, leading to soiled utensils with residue.