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.
Myriad basic records were either fake or missing, the letter says. These include raw material and API test results, cleaning and process validation reports and batch records, among others. The firm did provide records showing they performed annual reviews of their operation to ensure quality. But guess what? They were faked.
The company makes OTC products such as hand sanitizer, body lotion, sunscreen products and lipsticks, which it’s selling to more than 20 foreign countries including the U.S., Japan and Germany, its website shows. The warning letter specifically mentioned sunscreen products, which the FDA classifies as OTC drugs.
Now, the FDA considers all Ningbo Huize’s drugs to be adulterated. After putting the plant on an import alert list that forbids its drugs from entering the U.S., the FDA has followed with the warning letter. The company has agreed to a voluntary recall, according to the FDA.
To change the FDA’s mind, the company is advised to hire an independent consultant, run a comprehensive investigation into the data manipulation and come up with a detailed corrective action plan to ensure such violations won’t happen again.
The FDA’s ability to police the foreign drug supply has come into doubt amid recalls of “sartan” blood pressure drugs tainted with possible cancer-causing molecules.
During its inspections in the past, the agency has encountered cases where drug manufacturers refused to hand over records outright, or shredded records before the FDA arrived. At least Ningbo Huize’s management actually admitted their documents were produced specifically for the inspection.
But all these events speak to the reasoning behind a recent proposal by Sen. Chuck Grassley: The influential Republican senator, chair of the Senate Finance Committee, is calling on the FDA to run unannounced inspections, particularly in India and China, the two largest drug suppliers to the U.S.