Teva Receives FDA Warning Letter for Chinese API Plant

Teva Pharmaceutical Industries has received a Warning Letter from the US Food and Drug Administration (FDA) for the company’s active pharmaceutical ingredient (API) facility in China. The letter is related to a routine cGMP inspection conducted by the FDA at the API plant from September 26 to 29, 2016, according to a Teva filing with the US Securities and Exchange Commission (SEC) in April 2017.

The letter cites concerns with manufacturing control and sampling processes. Teva is in the process of undertaking corrective actions to address both the specific concerns raised by investigators as well as the underlying causes of those concerns. Communication with the FDA is ongoing. Teva will respond to the Warning Letter by May 1, 2017, it stated in its filing.

During its inspection, the FDA observed a failure to establish written procedures to monitor the progress and control the performance of processing steps that may cause variability in API quality and failure to establish a sampling plan based on scientifically-sound sampling practices. Among the items Teva must include in its response, the FDA requires the company to provide an improved corrective and preventative action plan; a list of past and current process parameters for API manufacturing, including their impact on quality, limits, and justification if monitoring and controlling of any of the parameters are ceased during commercial batch manufacture; and overall quality system improvements.

Teva received a Warning Letter from the FDA in October 2016 from a cGMP inspection of its manufacturing facility in Godollo, Budapest, Hungary. The FDA conducted the inspection at this site from January 21 to January 29, 2016, according to a Teva filing in October 2016 with the SEC. The Warning Letter for the Godollo facility cited deficiencies in manufacturing operations and laboratory controls and in Teva’s data-integrity program. Teva responded to the letter in November 2016.

Source: Teva Pharmaceutical Industries’ filing with the US Securities and Exchange Commission and Food and Drug Administration

*Editors note: article has been updated to include source information from the FDA Warning Letter.

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