FDA 483 - Bel Star S.A. - December 13, 2019

Bel Star S.A., an OTC drug product manufacturer in Tocancipa, Colombia, received a Form 483 with four observations primarily concerning significant data integrity failures and inadequate controls. The inspection revealed widespread issues with electronic records, including lack of unique user access, insufficient data backup, and editable audit trails, alongside deficiencies in equipment maintenance, laboratory controls, and personnel training. Additionally, basic sanitation requirements were not met, as hot water was absent in handwashing facilities throughout the plant.