FDA 483 - Buderer Drug Company - February 14, 2019

On February 14, 2019, the FDA issued a Form 483 to Buderer Drug Company, a producer of non-sterile drug products located at 38530 Chester Road, Suite 400, Avon, Ohio 44011. The inspection, conducted from February 7-14, 2019, identified one observation.

The primary violation noted was the use of a non-pharmaceutical grade component, [(b) (4)], in the formulation of non-sterile drug products, specifically topical creams for severe muscular pain. From 2012 to 2019, approximately [(b) (4)] prescriptions were produced using this component. Examples include Ketoprofen 5% Gel, prepared [(b) (4)] times, and [(b) (4)] base, used in over [(b) (4)] different non-sterile drug formulas, resulting in [(b) (4)] prescriptions. Additionally, from 2013 to 2019, a cream named Ultracaine-Benzocaine 20%, Lidocaine 8%, Tetracaine 4%, Ibuprofen 2%, Bupivacaine 0.5% also utilized [(b) (4)]. The FDA found no evidence that the [(b) (4)] used in these creams and liquid non-sterile drug products was of appropriate quality for its intended use.