Strides Pharma, Inc. – FDA 483, Jun 5, 2019

Par Pharmaceutical, Inc. in Chestnut Ridge, NY, received a Form 483 citing significant deficiencies in their manufacturing processes and laboratory controls. The inspection revealed inadequate written procedures for equipment cleaning validation and maintenance, including a flawed matrix approach and lack of defined cleaning times. Additionally, laboratory controls were found to be deficient, with analytical methods for drug product purity failing to quantify known impurities.