US FDA slams two Chinese API makers for quality systems and data issues

By Dan Stanton

- Last updated on GMT

image: iStock/Blablo101
image: iStock/Blablo101

Related tags Food and drug administration Pharmaceutical drug

Quality system and data integrity issues have landed two Chinese API makers with US FDA warning letters.

Shanghai Desano Chemical Pharmaceutical received a warning letter​ earlier this month, after inspectors from the US Food and Drug Administration (FDA) found significant deviations from current good manufacturing practice (cGMP) at the firm’s active pharmaceutical ingredient (API) facility in Pudong District, Shanghai in May 2015.

“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,”​ the FDA stated.

The Agency told the firm to respond by providing an investigation into the extent of the inaccuracies in data records and reporting, and to include interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies.

The FDA also asked for a current risk assessment of the potential effects of the observed failures on the quality of your drugs from Desano.

“Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity, and risks posed by ongoing operations.” contacted Desano for further details but did not receive a reply by the time of going to press.

Chongqing Lummy Pharmaceutical

A warning letter was also sent to fellow API maker Chongqing Lummy Pharmaceutical for deviations from cGMP seen during an FDA inspection at its Chongqing facility.

The Agency cited the firm’s failure to prevent unauthorised access or changes to data, and failure to document manufacturing operations at the time they are performed.

“During the inspection, our investigator reviewed 20 executed batch manufacturing records and found that most of them contained similar or identical entries that could not be adequately explained,”​ the FDA wrote.

“When our investigator asked your production supervisor to explain why the time stamps were identical on [API manufactured between January and February 2015] records, the production supervisor stated that the full manufacturing process takes (b)(4) to complete, and that all batch records are kept in the production area until (b)(4) lots are completed.

“The production supervisor stated that the operators most likely did not record the actions at the time they were performed but rather completed batch records in groups.”

Increased oversight

The warning letters are the latest in a number for Chinese and Taiwanese drug and ingredient makers, and according to the FDA this is due to increased oversight in the region.

Drug inspections in China have been increasing​,” an FDA spokesperson told us in January​. “The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 required the FDA to achieve the same inspection schedule for foreign facilities as domestic manufacturers.”

The Agency has made a concerted effort to increase its presence in China, pushing the number of regional staff from eight to 26 by pledging extra funds to boost its regional team​, and lobbying the Chinese Government to secure visas​ for the new drug manufacturing site inspectors.

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