FDAnews Drug Daily Bulletin

Chinese Company Gets Warning Letter After Barring FDA Investigators

Nov. 8, 2016

A pharmaceutical company in Beijing has received a warning letter from the FDA after barring investigators from the facility as well as falsifying and backdating records.

According to the letter, last November investigators went to the Beijing Taiyang Pharmaceutical Industry facility and observed drums bearing the company’s logo through a window; when investigators asked to gain access to the facility, they were barred from entering or examining the drums without a reasonable explanation.

Investigators were granted access to the facility the next day, but they noticed a significant number of the drums they saw had been removed and no explanation was provided. Once granted access, investigators discovered unexplained deletions of laboratory test results and found that the firm repeated tests until they obtained acceptable results. In addition, the firm failed to investigate out-of-specification or otherwise undesirable test results.

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