23 Aug 2019
FDA Targets Mainland Chinese Sunscreen Manufacturer for CGMP Violations
The Food and Drug Administration recently sent a warning letter to a mainland Chinese sunscreen manufacturer found to have quality control deficiencies. The warning letter to Ningbo Huize Commodity Co. of Yuyao, Zhejiang, an over-the-counter drug manufacturer, cited significant “current good manufacturing practice” violations. The targeted products are sunscreen lotions, which fall under the purview of the FDA as OTC drugs.
The letter followed an on-site inspection conducted last March. The FDA claims that the mainland Chinese firm provided FDA investigators multiple documents that were falsified, including the cleaning validation reports and batch production and control records for multiple drugs. The company also later admitted that records of periodic quality reviews had been falsified. The FDA placed the company on “import alert” in June to prevent these products from entering the U.S. market.
The warning letter requested a response from the company within 15 working days of receipt. Failure to correct the identified violations will result in the FDA continuing to refuse admission of these products. In order to remediate the significant quality control and data integrity problems, the FDA provided an extensive list of needed quality control improvement procedures, both in terms of supplier inputs and the manufacturing processes used. These include all manufacturing and cleaning processes as well as all testing data and documentation. The FDA also recommended engaging a qualified independent consultant to assist in meeting CGMP requirements, as described on FDA guidance websites.
In addition to manufacturing issues, the FDA objected to misbranding of the sunscreen lotions through inadequate labelling. The agency requires that sunscreen labels follow certain protocols, including with regard to directions for use, timing of application and specific warnings.
While the FDA noted that most manufacturers are complying with the CGMP regulations and following technical standards, it pledged to continue to “ensure that drug manufacturers around the globe meet the required standards for drug quality that American consumers expect.”
Meanwhile, Senate Finance Committee Chairman Charles Grassley (Republican-Iowa) is urging the FDA to reinstate unannounced inspections of prescription drug manufacturing facilities in foreign countries. In a recent letter, Grassley said that in light of a new Trump administration plan on drug importation and the fact that foreign facilities provide 80 percent of active pharmaceutical ingredients for drug production inside the United States, it is important to determine more accurately if these facilities meet set standards of quality and safety for both domestic and importation purposes. However, he pointed out that the FDA only inspected one in five registered human drug manufacturing facilities abroad in 2018, does not track whether a foreign inspection was announced or unannounced, and in fact generally does not perform unannounced visits of drug manufacturing facilities in foreign countries.
Grassley called for unannounced inspections in light of the apparent successes of a pilot programme the FDA conducted in India from 2013 to 2015 that eliminated advance notice and employed other measures to increase the secrecy concerning facility inspections. According to reports, Grassley said, this approach “exposed widespread malfeasance” and yielded a 60 percent increase in FDA “official action indicated” findings.