Norbrook Laboratories Limited – FDA 483, Apr 4, 2025

Norbrook Laboratories Limited, an animal drug product manufacturer, received a Form 483 with seven observations indicating significant deficiencies across multiple quality systems. The inspection revealed critical issues including inadequate sterile manufacturing procedures, environmental monitoring failures, deficient OOS investigations, non-stability-indicating analytical methods, poor equipment cleaning, lack of data integrity for QC testing, and inadequate complaint handling. These findings led to Field Alert Reports and a halt in manufacturing and distribution of sterile drug products to the U.S. market.