# FDA 483 - Nortec Quimica SA - July 22, 2022

Source: https://www.keypedia.com/records/483/nortec-quimica-sa/eb3791ab-d1b7-41b5-b4f6-2069cc04f242

> FDA 483 for Nortec Quimica SA on July 22, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nortec Quimica SA
- Inspection Date: 2022-07-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Nortec Quimica S.A., an API manufacturer in Duque de Caxias, Brazil, was cited for significant deficiencies during an FDA inspection. Observations included failures in quality unit oversight, lack of stability data for exported APIs, uncontrolled analytical records, and critical data integrity issues with computerized systems lacking proper access controls and backup procedures. These findings indicate a lack of robust quality control and data management practices.

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

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

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