FDA 483 - Laboratorios Haymann S.A. - May 16, 2011

An FDA inspection of Laboratorios Haymann S.A. in Montevideo, Uruguay, a manufacturer of drug products and active pharmaceutical ingredients, revealed two significant observations. The firm failed to follow written procedures for equipment cleaning, as evidenced by observed residue on equipment marked as clean. Additionally, multiple batches of Active Pharmaceutical Ingredient (API) were not included in the stability monitoring program.