The FDA issued a warning letter to Hong Kong-based OTC drugmaker Nan San Pharmaceutical for failing to conduct appropriate laboratory testing and marketing misbranded products in the U.S.
An inspection of the company’s facility in Kwun Tong Kowloon, Hong Kong last September resulted in Nan San being placed on the regulatory agency’s import alert list in January.
In its warning letter, the FDA says inspectors found the company failed to perform microbial limit tests on batches of one of its products from 2013 to 2016. It found Nan San performed microbial limit testing on one batch in 2013 and used those results to release “subsequently-manufactured batches” to the U.S.
Additionally, the agency cited the company for setting expiration dates for some of its products without properly determining the stability characteristics of those products.
Musflex and Easy-Flex, two of Nan San’s OTC products, were found to be misbranded because their labels didn’t list active or inactive ingredients.
The FDA recently hit another Chinese OTC drugmaker, Zhejiang Ludao Technology, with a warning letter for data integrity and product testing issues.