# FDA 483 - Laboratorios Rety de Colombia S A S - December 06, 2019

Source: https://www.keypedia.com/records/483/laboratorios-rety-de-colombia-s-a-s/f36de1a9-42a0-4be8-96f6-f84b7c3af4bd

> FDA 483 for Laboratorios Rety de Colombia S A S on December 06, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Laboratorios Rety de Colombia S A S
- Inspection Date: 2019-12-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Laboratorios Rety de Colombia S A S in Barranquilla, Colombia, revealed two significant observations. The firm failed to perform assay testing for finished drug products prior to release, relying instead on bulk product testing without scientific justification. Additionally, control procedures for manufacturing processes were found to be inadequate, specifically regarding the validation of critical process parameters.

## Related Officers

- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)

Company: https://www.keypedia.com/companies/laboratorios-rety-de-colombia-s-a-s/97d9f0e5-046a-4e02-9206-51b0d1ae4394

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1