The agency made the request in a warning letter last week, explaining: “We acknowledge that you have committed to verifying and validating your test methods, but you did not include a plan to evaluate APIs within expiry that were distributed to the United States.”
US Food and Drug Administration (FDA) inspectors who visited the Hachimantai facility identified incomplete data records and evidence some results had been deleted without justification.
“Numerous data files were found in the recycle bin folder on the computer connected to gas chromatography instruments GC-4 and GC-6” it said, adding that these included results of tests designed to identify the presence of residual solvents in drug ingredients.
The FDA also found problems with the system Sekisui uses to store test results, specifically that it lacks “controls to prevent deletion of and alterations to electronic raw data.”
The agency suggested Sekisui hire an external consultant and provide a detailed remediation plan.
Sekisui Medical is a subsidiary of Sekisui Chemical.
The firm’s portfolio includes antiseptics, antihistamines as well as ingredients for pancreatic disease medications.
Publication of the FDA’s letter comes just weeks after Sekisui announced it would invest JPY100m ($901,000) in addition API production capacity at the site. Construction of the facility is due to start next year.