# FDA 483 - Rio Biofarma Brasil Ltda - May 09, 2024

Source: https://www.globalkeysolutions.net/records/483/rio-biofarma-brasil-ltda/cd70d835-9e3b-455c-9f02-6fd8d2dc5496

> FDA 483 for Rio Biofarma Brasil Ltda on May 09, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Rio Biofarma Brasil Ltda
- Inspection Date: 2024-05-09
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of RIO BIOFARMA BRASIL LTDA in Hortolandia, Sao Paulo, a sterile drug manufacturer, revealed significant deficiencies in laboratory controls, process validation, and quality control procedures. The firm failed to establish adequate specifications, prevent microbiological contamination, thoroughly investigate discrepancies, and properly revalidate processes. These issues collectively indicate a serious lack of control over drug product identity, strength, quality, and purity.

## Related Documents

- [483 - 2022-08-02](https://www.globalkeysolutions.net/records/483/rio-biofarma-brasil-ltda/a3ce097d-3d9c-47f5-bb8d-02d6db0b5081)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/geoffrey-k-kilili/b00aeedf-95bd-4ccf-a23e-6e12e60249c4)
- [Eric A Wai](https://www.globalkeysolutions.net/people/eric-a-wai/425d1ca0-49a6-47f1-995a-84a187e11503)
- [Ebony D. Sanon](https://www.globalkeysolutions.net/people/ebony-d-sanon/703dc125-1019-43d1-9598-1bdc92026e2b)
- [Michele L. Glendenning](https://www.globalkeysolutions.net/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)

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