# FDA 483 - Rio Biofarma Brasil Ltda - August 02, 2022

Source: https://www.globalkeysolutions.net/records/483/rio-biofarma-brasil-ltda/a3ce097d-3d9c-47f5-bb8d-02d6db0b5081

> FDA 483 for Rio Biofarma Brasil Ltda on August 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rio Biofarma Brasil Ltda
- Inspection Date: 2022-08-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of RIO BIOFARMA BRASIL LTDA, a sterile drug manufacturer in Hortolandia, Brazil, revealed significant deficiencies in aseptic processing controls and quality unit oversight. The firm failed to implement adequate environmental monitoring during sterile operations and did not properly review raw data from chromatography systems. Additionally, laboratory records lacked specifications, leading to unreported out-of-specification results for stability studies.

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- [483 - 2024-05-09](https://www.globalkeysolutions.net/records/483/rio-biofarma-brasil-ltda/cd70d835-9e3b-455c-9f02-6fd8d2dc5496)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/rio-biofarma-brasil-ltda/ce7dde3a-6b6c-45e5-a8bc-3f8f518527a9

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