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

Source: https://www.keypedia.com/records/483/ecorganicos-de-colombia-sas/0eedb422-64f4-4fe5-be38-d46318b5cd40

> FDA 483 for Ecorganicos de Colombia SAS on December 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ecorganicos de Colombia SAS
- Inspection Date: 2019-12-06
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: 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.

## Related Officers

- [Jason R. Caballero](https://www.keypedia.com/people/jason-r-caballero/c2c8d281-0d02-459f-9541-bc04cb6d0a59)

Company: https://www.keypedia.com/companies/ecorganicos-de-colombia-sas/18f8db7b-fe46-4f3c-9268-53688ebb2330

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9