Two Chinese OTC Pharmaceutical Manufacturing Plants Receive FDA Warning Letters

Zhejiang Ludao Technology Co., Ltd. and Nan San Pharmaceutical Factory Ltd., have received warning letters from the FDA over their failure to adequately respond to pharmaceutical manufacturing issues previously identified by the regulator. In both cases, the FDA recommended the drugmakers seek out a cGMP consultant to help them get their manufacturing processes up to par.

The two warning letters – both issued in February – are the first to be issued to OTC pharmaceutical manufacturers in 2018. Manufacturers of OTC drug products were a particular target of the FDA in 2017, with a total of 22 warning letters sent out to these producers.

At Zhejiang Ludao Technology’s plant in Taizhou, China, the FDA inspection found that laboratory records included incomplete data and that no measures were put in place to prevent paper and electronic records from being changed. The manufacturer also admitted to falsifying test results on certificates of analysis (COA) for multiple batches of OTC drugs which were then distributed and sold in the US.

“In your response, you provided a revised procedure that requires retention of all test-related records and implements routine data review,” said the warning letter. “Your response also committed to upgrading your analytical instrumentation to comply with CGMP requirements. However, your response was insufficient.”

Nan San Pharmaceutical Factory Limited’s Hong Kong site was cited for failing to ensure that each batch of drug product was tested for conformance, strength and the presence of contamination, including microorganisms, before releasing the products for sale in the US.

“Your firm failed to test all batches of over-the-counter (OTC) topical liquid analgesics for conformance to their specifications before releasing each batch,” said the warning letter. “For example, you did not perform microbial limit tests for each batch of your Easy-Flex analgesic lotion released between 2013 and 2016. Instead, you performed microbial limit testing on one batch in 2013 and reported the same results to release subsequently-manufactured batches to the United States.”

The FDA gave both OTC drug manufacturers 15 business days to respond to the warning letters, which were sent out on February 23^rd. Both manufacturers were also put on an import alert list, which allows inspectors to detain drug products produced at these facilities to prevent them from entering the US marketplace.