Chinese API Manufacturer Is Latest to Receive Warning for Data Integrity as Scrutiny Intensifies

The FDA last week issued its 13th warning letter in 2014 for data integrity violations, out of 18 total warning letters released over good manufacturing practices, with foreign facilities drawing most of the criticisms.

The letter, released Dec. 30, chided Novacyl Wuxi Pharmaceutical, a Chinese API maker, for data integrity and other GMP violations stemming from an October 2013 inspection of its Jiangsu, China, facility.

Investigators, for example, discovered that personnel had thrown away a chromatogram result for an API that was out of specification, and that the manufacturer didn’t use separate passwords for each analyst’s access to the laboratory systems, the letter said.

The focus on data integrity in 13 of 18 GMP warning letters in 2014 stands in sharp contrast to 2013, when it was cited in only seven out of 26 GMP warning letters.

The latest letter also is more evidence that the FDA is making good on its promise of focusing on the issue after a spike in findings at international facilities (DID, Oct. 24, 2014).

Novacyl was not available for comment. To read the warning letter, visit www.fdanews.com/12-30-14-NovacylWarning.pdf. — Robert King