FDA 483 - Ecorganicos de Colombia SAS - December 06, 2019

Ecorganicos de Colombia SAS, an API manufacturer in Bogota, Colombia, was cited for numerous significant deficiencies during an FDA inspection. Observations included a lack of equipment cleaning and maintenance procedures, absence of validation for critical processes, uncalibrated equipment, and insufficient stability testing for API products. The firm also lacked essential written procedures for material acceptance, product recall, and comprehensive batch production records, indicating a systemic failure in maintaining adequate quality control for products intended for the U.S. market.