FDA 483 - Grupo Quimico SRL - November 22, 2023

Grupo Quimico SRL, a contract testing laboratory in Montevideo, Uruguay, was inspected by the FDA and received a Form 483. The inspection revealed significant deficiencies in data integrity, method validation, laboratory controls, and record-keeping practices. These issues indicate a lack of adequate controls to ensure the accuracy and reliability of analytical data for US OTC drug products and raw materials.