FDA 483 - Jost Chemical Co. - October 13, 2023

Jost Chemical Co., an API manufacturer in Saint Louis, MO, was cited for two significant observations during an FDA inspection. The firm failed to establish and follow written investigation procedures for critical deviations and out-of-specification products, specifically regarding microbial contamination of Zinc Citrate Dihydrate. Additionally, equipment was found to be improperly designed with air gaps and not adequately cleaned, posing a risk of contamination to various API products.