# FDA 483 - Sagent Pharmaceuticals - December 18, 2019

Source: https://www.globalkeysolutions.net/records/483/sagent-pharmaceuticals/cdb3159c-250b-4e80-b62d-bf743d51a811

> FDA 483 for Sagent Pharmaceuticals on December 18, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sagent Pharmaceuticals
- Inspection Date: 2019-12-18
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Sagent Pharmaceuticals Inc. in Schaumburg, IL, received a Form 483 with seven observations highlighting significant deficiencies in its quality control unit's oversight of contract manufacturers and adherence to procedures. The firm failed to ensure proper approval and rejection of drug products, investigate temperature excursions, and submit timely field alert reports for contamination and out-of-specification products. These issues, coupled with inadequate staffing and documentation errors, indicate a systemic breakdown in quality assurance and regulatory compliance.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/vioela-j-caze/919a30c8-26e5-4908-a73c-4e8cba5692cf)
- [Rita Kabaso](https://www.globalkeysolutions.net/people/rita-kabaso/a8383d6d-b945-4edc-97a4-90944574835d)

Company: https://www.globalkeysolutions.net/companies/sagent-pharmaceuticals/9b7830c1-51dd-4d82-8287-b320eff537fd

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8