# FDA 483 - União QuÍmica Farmacêutica Nacional SA - August 06, 2018

Source: https://www.globalkeysolutions.net/records/483/uniao-quimica-farmaceutica-nacional-sa/23f41198-0701-4753-9b4d-fcd0d709fb78

> FDA 483 for União QuÍmica Farmacêutica Nacional SA on August 06, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: União QuÍmica Farmacêutica Nacional SA
- Inspection Date: 2018-08-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Inovai Industria Farmaceutica Ltda., a sterile veterinary drug product manufacturer in Villa Saint Anna Guarulhos, Sao Paulo, Brazil, was cited for two significant observations. The inspection revealed failures in establishing and following procedures to prevent microbiological contamination of sterile drug products, particularly concerning media fills and environmental monitoring. Additionally, the firm failed to consistently follow written production and process control procedures, as evidenced by undocumented interventions during media fill studies.

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- [Quality System Specialist](https://www.globalkeysolutions.net/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)

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

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