FDA 483 - Haleon US Inc. - September 30, 2021

An FDA inspection of GSK Consumer Health Inc. in Lincoln, NE, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to thoroughly review out-of-specification materials and packaging defects, leading to distributed products with potential quality issues. Additionally, there were inadequate written procedures for the quality control unit, equipment cleaning, microbial control in water systems, and the drug product stability program.