The US Food and Drug Administration (FDA) has issued a warning letter to Yuki Gosei Kogyo Co., Ltd after an inspection of its Fukushima, Japan-based active pharmaceutical ingredient (API) facility in November last year.
According to the FDA, the inspection revealed the firm had failed to maintain complete data, designed to ensure the quality of API production. In addition, Yuki Gosei Kogyo staff admitted to finding additional instances of unreported electronic data in original batch records, said the Agency.
“Your review only assessed laboratory data and did not assess all parts of your facility’s operation where cGMP (current good manufacturing practice) information is generated and maintained. In addition, you failed to provide details of your review criteria and methodology,” the FDA added.
The US regulator has requested Yuki Gosei Kogyo provide documents, including interviews with current and former employees, to identify the root cause of data inaccuracies, and an assessment of the extent of the firm’s data integrity deficiencies: “Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies.”
The FDA has also requested a customer risk analysis: “Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity, and risks posed by ongoing operations.”
The firm did not respond to a request for comment ahead of publication.