FDA 483 - CooperSurgical, Inc. - March 04, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · cae64b1c-d57c-4a99-9abb-291ea0fb2e32