# Uniao Quimica Farmaceutica Nacional SA – FDA 483, Aug 9, 2023

Source: https://www.keypedia.com/records/483/uniao-quimica-farmaceutica-nacional-sa/284da216-e0ef-48e5-84d4-b94e972d7b26

> FDA 483 for Uniao Quimica Farmaceutica Nacional SA on August 09, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Uniao Quimica Farmaceutica Nacional SA
- Inspection Date: 2023-08-09
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Inovat Industria Farmaceutica Ltda., a sterile drug manufacturer in Guarulhos, Sao Paulo, Brazil, revealed significant deficiencies. The firm's complaint handling procedures were found to be inadequate, failing to ensure proper quality unit review and investigation of product failures. Additionally, the company lacked established control procedures to monitor manufacturing output and validate process performance, specifically regarding unchallenged yield specifications and uninvestigated out-of-specification results for US-market products.

## Related Documents

- [483 - 2018-08-06](https://www.keypedia.com/records/483/uniao-quimica-farmaceutica-nacional-sa/23f41198-0701-4753-9b4d-fcd0d709fb78) — date: August 6, 2018
- [EIR - 2016-02-23](https://www.keypedia.com/records/eir/uniao-quimica-farmaceutica-nacional-sa/86115829-164e-45a6-9305-a3a45b44f407) — date: February 23, 2016
- [483 - 2012-12-11](https://www.keypedia.com/records/483/uniao-quimica-farmaceutica-nacional-sa/477fd40d-76a5-42cd-8049-7af614a21a77) — date: December 11, 2012

## Related Officers

- [Damaris Y. Hernandez](https://www.keypedia.com/people/damaris-y-hernandez/ca16093e-047b-4bf1-bcc1-c439cff21e8a)
- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)

Company: https://www.keypedia.com/companies/uniao-quimica-farmaceutica-nacional-sa/538e92cc-058f-4ca7-bf33-34caf7f329a5

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4