FDA 483 - Co-Innovation Biotech Co., Ltd. - January 09, 2020

Co-Innovation Biotech Co. Ltd., a medical device manufacturer in Guangzhou, China, was cited for multiple quality system deficiencies during an FDA inspection. Observations included a lack of validation for a seal tester used for HCG test kits, undocumented equipment calibrations, and inadequate documentation of corrective and preventive actions. The firm also failed to record environmental conditions as required and used unapproved forms, indicating significant issues with their quality management system.