Biocosmetica Excel Argentina S.R.L. – FDA 483, Jul 7, 2022

Biocosmetica Excel Argentina S.R.L., an OTC drug manufacturer in San Justo, Argentina, was cited for multiple deficiencies during an FDA inspection. The observations primarily concern inadequate laboratory controls, insufficient component testing, lack of validation for computer systems and equipment, and absent or deficient written procedures for quality systems, production records, and equipment maintenance. These issues indicate a general lack of adherence to good manufacturing practices.