FDA 483 - Nostrum Laboratories, Inc. - March 13, 2025

Nostrum Laboratories, Inc. in Bryan, OH, was inspected by the FDA, revealing issues with laboratory controls and the stability program for drug products. Specifically, water testing procedures were found to be inadequate, and the stability testing method for Nitrofurantoin Oral Suspension lacked sufficient validation for impurity detection. These observations indicate deficiencies in ensuring product quality and purity.