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Teva Receives Second FDA Warning Letter in Six Months for International Facilities

April 24, 2017

Teva Pharmaceutical Industries received an FDA warning letter over its API manufacturing plant in China — the company’s second in six months.

The warning letter highlighted problems with manufacturing control and sampling processes found during an FDA inspection conducted last September at Teva Pharmaceutical & Chemical (Hangzhou) Co., in Hangzhou, China. The letter has not been made public by the FDA but was disclosed in an SEC filing.

Teva said it is undertaking corrective actions and is communicating with the agency, with plans to respond to the letter by May 1.

In October, Teva received a warning letter following sterility testing and contamination issues at a separate plant in Hungary. That letter said Teva did not thoroughly investigate sterility test positives, and investigations did not adequately assess the hazards in aseptic manufacturing operations.

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