483
Ajinomoto Health & Nutrition North America, Inc.FDA 483 - Ajinomoto Health & Nutrition North America, Inc. - November 13, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
- Inspection Date
- November 13, 2023
- Product Type
- Drugs
Open in Dashboard
ID · 206504e1-c548-452f-9087-6094e8f0937a