# FDA 483 - Ajinomoto Health & Nutrition North America, Inc. - November 13, 2023

Source: https://www.globalkeysolutions.net/records/483/ajinomoto-health-nutrition-north-america-inc/206504e1-c548-452f-9087-6094e8f0937a

> FDA 483 for Ajinomoto Health & Nutrition North America, Inc. on November 13, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Ajinomoto Health & Nutrition North America, Inc.
- Inspection Date: 2023-11-13
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Ajinomoto Health & Nutrition North America, Inc. in Eddyville, IA, revealed significant deficiencies in the manufacturing of crude intermediates for active pharmaceutical ingredients. The firm lacked a quality control unit, proper process validation, and scientific justification for hold times and shelf-life. Additionally, issues were noted with incomplete batch records and inadequate controls for electronic data integrity.

## Related Documents

- [483 - 2025-09-12](https://www.globalkeysolutions.net/records/483/ajinomoto-health-nutrition-north-america-inc/4ff497bd-360a-470f-a34e-e5b3e8f9c6c9)

## Related Officers

- [Lori B. Wikstrom](https://www.globalkeysolutions.net/people/lori-b-wikstrom/19d938f7-4a5d-42b9-b2d1-e92cdb63bb0d)

Company: https://www.globalkeysolutions.net/companies/ajinomoto-health-nutrition-north-america-inc/b9d2156b-cff2-47e8-8519-5f63178995d2

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