FDA 483 - Buderer Drug Company - February 14, 2019

This FDA Form 483 document details inspectional observations at Buderer Drug Company, a producer of non-sterile drug products, located at 38530 Chester Road, Suite 400, Avon, Ohio 44011. The inspection was conducted by Consumer Safety Officer Jazmine N. Still from February 7, 2019, to February 14, 2019. Matthew J. Buderer, Owner and Pharmacist, was the recipient of the report.

The sole observation noted was the use of a non-pharmaceutical grade component, EVERCLEAR 95% GRAIN ALCOHOL, in the formulations of 19 non-sterile drug products, specifically topical creams for severe muscular pain. The firm reportedly used this component to produce approximately 200 non-sterile drug prescriptions between 2012 and 2019.

Specific examples cited include: A. Ketoprofen 5% Gel, prepared using EVERCLEAR 95% GRAIN ALCOHOL 40 times from 2012 to 2019. B. A base, used as a component in various non-sterile drug formulas, was prepared using EVERCLEAR 95% GRAIN ALCOHOL in 164 prescriptions from 2012 to 2019. C. From 2013 to 20