FDA 483 - Eagle Labs Inc. - December 06, 2023

During an FDA inspection from November 29 to December 6, 2023, Eagle Labs Inc., a contract manufacturer in Seminole, FL, was cited for two observations. The firm failed to follow written procedures for equipment cleaning and maintenance, including issues with major cleans and cleaning validation for non-dedicated drums. Additionally, the inspection found that written production and process control procedures were not followed and documented correctly during process validation activities.