Ajinomoto Althea, Inc.January 16, 2023

FDA 483 - Ajinomoto Althea, Inc. - January 16, 2023

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

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.

Explore Ajinomoto Althea, Inc.

Record Details

Ajinomoto Althea, Inc. DBA Ajinomoto Bio-Pharma Services in San Diego, CA, was inspected and received a Form 483 with three observations. The inspection revealed deficiencies in quality oversight of validation activities, facility and equipment maintenance, and adherence to quality control unit procedures. These issues indicate a need for improved GMP compliance in critical manufacturing and laboratory operations.

Company: Ajinomoto Althea, Inc.
Inspection Date: January 16, 2023
Product Type: Biologics
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Yi Wang (Regulatory Scientist at FDA)
Christopher R. Czajka (Consumer Safety Officer (Inspector))
Michael R. Shanks (Investigator)

Open in Dashboard

ID · 31d386f5-e5ea-4cf9-b563-54c74ade61ef