# FDA 483 - The Ritedose Corporation - February 28, 2025

Source: https://www.globalkeysolutions.net/records/483/the-ritedose-corporation/87f51749-0d74-4cf5-9505-4d582b6c01e1

> FDA 483 for The Ritedose Corporation on February 28, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: The Ritedose Corporation
- Inspection Date: 2025-02-28
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: The Ritedose Corporation, a sterile drug manufacturer, received an FDA Form 483 citing significant deficiencies in facility maintenance, aseptic process validation, and discrepancy investigations. Observations included insanitary conditions and structural damage in cleanrooms, inadequate airflow visualization studies for sterile drug production, and a failure to thoroughly investigate critical pressure excursions. These issues indicate a potential for product contamination and a lack of robust quality control.

## Related Documents

- [483 - 2022-03-18](https://www.globalkeysolutions.net/records/483/the-ritedose-corporation/97655b10-9242-4af1-9436-3085ab30106f)

## Related Officers

- [Pharmaceutical Specialist/ Investigator ](https://www.globalkeysolutions.net/people/veronica-fuentes/50ea657f-39e6-4d97-a627-86339df3fbe6)
- [Andrew O. Ejiofor](https://www.globalkeysolutions.net/people/andrew-o-ejiofor/6f256c75-79a4-41a0-a51b-480d5db8f3da)

Company: https://www.globalkeysolutions.net/companies/the-ritedose-corporation/eb3f4c46-57bb-4bd6-a3ee-0fa0517ce0fa

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7