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FDA hits Japanese API maker with warning letter over lab data

The FDA slapped Japanese API maker Yuki Gosei Kogyo with a warning letter, citing the Tokyo-based company for failing to report lab testing data on released lots.
 
The warning letter was in response to an inspection conducted at the company’s facility last November. During that inspection, an investigator with the regulatory agency uncovered that out-of-specification results on a batch of API’s went unreported even though other data recorded on the same date for the same lot indicated passing results.

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