FDA Orders Dermatology Drug Manufacturer to Shut Down
The products include those intended for dermatological purposes, for instance, ointments, washes and creams that were never tested or approved to be sold in retail stores.
Officials with the FDA have announced that US District Judge Kathleen M. Williams, ordered manufacturer Sonar Products Inc. and distributor Stratus Pharmaceuticals Inc., and 2 of the firm’s officers, Alberto Hoyo and Juan Carlos Billoch to shut down operations, because they allegedly distributed “unapproved, faulty and mislabeled products to the public.”
These products include those intended for dermatological purposes, for instance, ointments, washes and creams that were never tested or approved to be sold in retail stores, violating the Federal Food, Drug, and Cosmetic Act, according to a statement from the FDA.
Sonar and Stratus also violated current good manufacturing practice (CGMP) requirements in 2014 after failing to address customer complaints. In addition, Sonar was inconsistent in cleaning their manufacturing equipment and did not use valid test methods on products before distribution.
A consent decree issued by the court orders the companies to hire a CGMP expert and cease operations until violations are corrected.
Sonar Products ordered to cease operations, Stratus Pharmaceuticals ordered to cease distributing unapproved drugs [news release]. FDA website. June 15, 2017. Accessed at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm563324.htm