Dive Brief:
- The Food and Drug Administration issued a warning letter earlier this month to Kyowa Hakko Bio's drug manufacturing facility in Yamaguchi, Japan.
- The letter, dated Aug. 10, said the FDA found significant deviations from current good manufacturing practices (CGMPs) for active pharmaceutical ingredients, including a failure of the quality unit to ensure compliance and failure of data controls.
- Kyowa Hakko is required to provide an assessment of its overall system for investigating failures and an independent review of data procedures, records and reporting within 15 working days.
Dive Insight:
Asian drugmakers are leading the pack in number of manufacturing-focused warning letters issued this year. While fairly common to see a letter headed to a China- or India-based company, it's quite rare for the recipient to be a manufacturer in Japan, where only a couple warnings have been sent in 2018.
The letter to Kyowa claims the company's quality unit failed to ensure active pharmaceutical ingredients manufactured at its facility were in compliance with CGMP. According to the letter, the company admitted its system suitability test did not conform and that some data was manipulated to meet specifications.
"Your response stated that no product in distribution was found to be [out of specification] OOS, but you included no data to support this conclusion," wrote Francis Godwin, acting director of the FDA Office of Manufacturing Quality, in the letter. "Your response is inadequate. You identified additional data integrity issues, but failed to provide details regarding the corrective measures your firm has implemented."
The letter also says the company did not password-protect equipment or spreadsheets, calling the reliability of the data into question.
This isn't Kyowa Hakko's first warning either. They previously received a letter in September 2010 that cited similar deviations at the Hofu site, and a September 2017 inspection also found problems at the company's facility in Ube. The warning letter described repeated failures at multiple locations as evidence "that executive management oversight and control over the manufacture of drugs is inadequate."
"The FDA's observations include concerns about data integrity," Kyowa said in a brief Aug. 21 statement. "We confirm that there are no quality deficiencies in our products. At this time, we are not instructed to recall our products and/or suspend shipments due to this [warning letter]."
The Yamaguchi Production Center became the core of Kyowa Hakko Bio when it spun out in 2008, and is home to basic fermentation technology and recombinant DNA technology platforms.