FDA 483 - Huvepharma Inc. - January 30, 2023

An FDA inspection of Huvepharma Inc. in Saint Louis, MO, a veterinary drug manufacturer, revealed deficiencies in preventing objectionable microorganisms in non-sterile drug products and in thoroughly investigating product specification failures. Specifically, issues included a leaking water purification system, lack of routine water testing for B. cepacia, and inadequate investigations into microbial contamination for products failing stability testing.