FDA warns another Japanese drug manufacturer over GMP flaws
- The Food and Drug Administration has warned Japanese drug manufacturer Sato Pharmaceutical of major GMP violations at its Tokyo-based facility for finished drug production after finding Sato's response to a Feb. 2016 inspection lacking.
- In a letter recently posted online, the regulator cited a lack of appropriate systems for monitoring conditions in aseptic processing areas, as well as shortcomings in the facility's air flow systems (which have since been remedied).
- The FDA recommended Sato hire a GMP consultant to help the facility meet compliance standards, but warned it could withhold approval for any new applications submitted that list the facility as a production site.
After flagging violations at 44 different companies drug manufacturers last year, the FDA is showing no signs of throttling back its stepped-up enforcement of overseas production facilities.
So far in 2017, the FDA's Office of Manufacturing Quality has flagged violations at 10 firms. In keeping with recent patterns, six of those 10 are located in China or India, which together make much of the world's supply of active pharmaceutical ingredients.
Unusually, however, two Japanese firms have been among those cited this year and a third was hit with a warning last September.
In addition to the warning letter to Sato, the FDA recently posted letters flagging violations at Bangalore, India-based Resonance Laboratories and at two Chinese plants owned by Zhejiang Bangli Medical Products Co. and Ausmetics Daily Chemicals.
- FDA Warning letter
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