The FDA does not think it is a good idea for the maker of an OTC oral rinse product to be manufacturing it on the same equipment it uses to produce a car polish which bears the warning “Harmful or fatal if swallowed.”
That is what the FDA said in a warning letter issued last month to ChemRite CoPac of Lannon, Wisconsin, a contractor that makes over-the-counter oral rinses and oral moisturizing drug products for a customer. During an inspection in 2016, FDA inspectors found a variety of problems, some of them repeats.
The FDA warning says that the manufacturer was making toxic nonpharmaceutical industrial and automotive care products, such as leather treatments, using the same mixing tank and filling line it used for OTC oral drug products. The FDA noted it is very difficult to remove those ingredients from the equipment and ordered ChemRite to stop the practice.
It also noted that the manufacturer was not testing the FDA-regulated products and had released 24 batches between 2013 and 2015 without determining whether they met microbiological finished product specifications. The agency was not satisfied with the company's explanation that its customer's testing had not found any microbial contamination.
The FDA also said that ChemRite's promises to fix similar issues after inspections in 2013 and 2016 had not been fulfilled, stating “These repeated failures demonstrate that your facility’s oversight and control over the manufacture of drugs is inadequate,” and warning that the FDA could take legal action if the company doesn't rectify the issues observed.
The FDA has had its sights on other OTC makers. Early this year, it cited Pharmco Laboratories, a maker of skincare products, after an inspection of its Titusville, Florida-based plant found issues with its processes for making OTC drugs as well as finished drugs and APIs.
Last year a Brazilian drug manufacturer promised the FDA it would no longer make its over-the-counter drugs for the U.S. market after learning they were regulated. Mappel Indústria de Embalagens of São Paulo, Brazil, said in response to an FDA inspection of its facility that when it began manufacturing products for the U.S. market, “it did not fully comprehend that such products were regulated by the FDA as OTC drugs.”