FDA 483 - Aromas Para El Alma S.A. - October 19, 2023

Aromas Para El Alma S.A., a non-sterile finished drug product manufacturer in Guachipelin, San Jose, Costa Rica, was inspected by the FDA. The inspection revealed significant deficiencies across multiple areas, including inadequate procedures for preventing microbial contamination, lack of written quality control unit responsibilities, insufficient production and process controls, unsupported expiration dates, and deficient batch records regarding component weights and yield calculations. These observations indicate a broad lack of adherence to good manufacturing practices.