FDA 483 - CooperSurgical, Inc. - March 04, 2022

CooperSurgical, Inc. in North Tonawanda, NY, a pharmaceutical drug manufacturer, received an FDA Form 483 citing significant quality control deficiencies. Observations included inadequate investigations into out-of-specification results and customer complaints, and a failure to thoroughly review manufacturing discrepancies. Additionally, the firm lacked scientifically sound laboratory controls for package seal integrity and detailed, validated cleaning and maintenance procedures for equipment.