US FDA hits Chinese API maker with warning after having inspection impeded

By Dan Stanton

- Last updated on GMT

Image: istock/dk_photos
Image: istock/dk_photos

Related tags Food and drug administration Pharmaceutical drug

Data integrity issues and the unexplained disappearance of drums of pharmaceutical ingredients have landed a Chinese API maker with a US FDA warning letter.

According to its website, Beijing Taiyang Pharmaceutical Industry Co. manufactures a number of active pharmaceutical ingredients (APIs) locally and for export to regions including the US from its facility in China’s capital.

But in April the firm was placed under two Import Alerts by the US Food and Drug Administration (FDA), which yesterday published a warning letter sent to the facility following a visit in November 2015, citing numerous deviations from cGMP including attempts by the firm to delay and limit the inspection.

“On November 16, 2015, our investigators observed through a window a warehouse containing numerous drums bearing your company’s label,” ​the Agency said in the letter​.

“When our investigators requested access to this warehouse, you barred them from entering the warehouse to examine the containers or the material in them without giving a reasonable explanation.”

While the inspectors were granted access the following day, they observed a significant number of drums had been removed and were not available for inspection.

“When they asked about the drums they had observed the previous day, you provided no explanation of the whereabouts or contents of the drums,”​ the letter continued.

“You delayed FDA’s access to the warehouse and limited FDA’s inspection by removing the drums before our investigators could inspect them.”

Data integrity and China

The API maker was also pulled up on failures to maintain manufacturing and laboratory control records and record all quality-related activities, and was unable to provide batch production records for certain batches during the inspection.

As such the Agency concurred the firm’s “quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,”​ and has recommended the company recruits a third-party consultant to aid in remediation.

The warning letter is the latest in a number for Chinese and Taiwanese drug and ingredient makers. In July​, the Agency released details of two other firms slammed with warnings.

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.”

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