The FDA doesn’t always announce the warning letters it slaps on drugmakers, much less send out a missive from the commissioner himself. But apparently, the agency considers one set of violations serious enough to publicly call out a Chinese over-the-counter drug manufacturer.
According to Ningbo Huize Commodity’s website, all its consumer health products are made “in full compliance with FDA’s regulations and guidelines.” But during an agency visit in March, the company handed over multiple quality control documents its general manager admitted were falsified “for the purpose of this inspection,” the agency said.
Besides offering up those tailor-made documents, the Ningbo, China-based company failed to produce some crucial cGMP records. In a warning letter the FDA just posted on its website, the agency says quality control supervision at the site was seriously lacking.