15/16 June 2023
During the pandemic, it was difficult to ensure the supply of necessary hygiene products, including disinfectants. In many countries, therefore, the framework conditions for production and marketing were eased. In our globalised world, this also led to products being placed on the market that attracted attention during inspections by the regulatory authorities due to deviations from the minimum requirements. We have already reported on some such cases in the recent past:
The FDA has now issued a warning letter to a Chinese manufacturer. According to the available documents, this company was responsible for the production of a number of over-the-counter drugs, including two hand sanitizers. After three unsuccessful written attempts and one unsuccessful telephone attempt by the FDA to obtain the necessary documents from this manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act, the FDA has now drawn the first consequences.
In its warning letter, the FDA writes "FDA has placed all drugs and drug products manufactured by your company on import alert 66-79 on May 16, 2022. Until FDA is able to confirm compliance with CGMP and other applicable requirements, we may deny approval of new applications or supplements listing your company as a drug manufacturer."
The full contents of the warning letter can be found on the FDA website at "Warning Letter - Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd."
The FDA's concerns for quality and safety do not only include hand disinfectants. Since the beginning of the COVID-19 pandemic, the disinfection of surfaces has also played a more important role than before. In addition to conventional disinfectants, there are now also devices on the market that use UV radiation, which is known to have a microbiocidal effect. However, not all devices on the market offer the required safety standard for the user. The FDA published a warning against so-called UV rods. In this letter, the FDA says: "FDA is aware that some manufacturers are marketing unsafe UV wands for disinfecting surfaces and killing germs in the home or similar non-healthcare settings. FDA recommends that consumers not use these products and consider safer alternative methods."
Prior to this, the FDA collected and reviewed a whole range of devices and from this compiled a list of devices that it found were not safe for users. More details can be found on the FDA site at "Do Not Use Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation: FDA Safety Communication".