# FDA 483 - Nortec Quimica SA - August 04, 2023

Source: https://www.keypedia.com/records/483/nortec-quimica-sa/8dc7628d-a12f-4fa9-bbae-8e06ffac9c5b

> FDA 483 for Nortec Quimica SA on August 04, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nortec Quimica SA
- Inspection Date: 2023-08-04
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: During an FDA inspection, Nortec Quimica, S.A., an Active Pharmaceutical Ingredient (API) manufacturer in Duque de Caxias, Brazil, was cited for a significant deficiency in its cleaning validation program. The firm's cleaning validation report was not representative of current equipment usage, specifically failing to account for changes in the worst-case scenario active pharmaceutical ingredient. This issue could impact the quality and safety of APIs manufactured for the U.S. market.

## Related Documents

- [483 - 2022-07-22](https://www.keypedia.com/records/483/nortec-quimica-sa/eb3791ab-d1b7-41b5-b4f6-2069cc04f242)

## Related Officers

- [Drug Enforcement Administration](https://www.keypedia.com/people/john-a-gonzalez/51074472-cb23-4b72-8ca7-2d973670063e)
- [Investigator](https://www.keypedia.com/people/demario-l-walls/c69c4c87-f001-45ab-8d7b-b45c60226ff1)

Company: https://www.keypedia.com/companies/nortec-quimica-sa/c294f0c3-f7c7-48db-8d53-36dd91178958

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3