Data Integrity Problems Found at Japan Facility

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FDA cites Sato Yakuhin Kogyo Co., Ltd. with data integrity violations after a June 2016 inspection of its Kashihara City facility.

On Jan. 6, 2017, FDA sent a warning letter to Sato Yakuhin Kogyo Co., Ltd. detailing current good manufacturing practice violations the agency observed during an inspection of the company’s facility located in Kashihara City, Nara Prefecture, Japan. The inspection, which occurred from June 6–10, 2016, found data integrity issues including incomplete laboratory records.

According to FDA, the company relied on incomplete data; duplicate impurity tests were performed but only some of the results were available for review. The original data were not maintained, and there was no documentation of why the analysis was repeated. Data on the company’s ultraviolet-visible spectrophotometer was also not maintained.

FDA stated the following to the company’s response regarding the data integrity failure: “You have not conducted a retrospective review to determine how your failure to maintain complete records affected the quality of your drugs. Moreover, you have not shown how your revised laboratory procedures prevent the deletion, manipulation, or exclusion of data from the records relied upon for batch release and other quality review decisions.”

Analysts at the company told FDA that, up until June 1, 2016, they were allowed to repeat testing without justification or documentation, nor were they required to maintain data. The company replied to the violation by assuring the agency that analysts would no longer be permitted to perform reanalysis and that testing results would be verified. FDA responded that the company’s quality unit should be involved in the new procedure. 


The agency has asked the company to perform an investigation into its protocols and methodologies, interview employees to determine the scope and cause of the data inaccuracies, and assess and evaluate the extent of the data integrity deficiencies at the company. The company was also asked to perform a risk assessment of the potential effects of the data failures on product quality, and create a corrective action and preventive action plan. The company must also provide FDA with more information on the company’s quality unit, validation reports, clean hold time study reports, and revalidation plans.

Source: FDA