Japanese Drugmaker Eisai Handed 483 Due to Data Integrity, Quality Concerns

The FDA served drug manufacturer Japanese drugmaker Eisai a Form 483 after an inspection of its Baltimore, Maryland facility revealed recordkeeping and quality control issues that led to incomplete data and unrestricted access to computers.

The agency listed five observations including that the company’s quality control managers have full access to chromatography data systems giving them the ability to alter and delete data as well as modify system settings. Additionally, the password to unlock sensitive spreadsheets was shared among analysts within the quality control laboratory. These observations raised concerns on the reliability of the company’s records.

The firm also failed to implement corrective and preventive measures in response to test failures of drug products and to follow established testing procedures.