Ajinomoto Althea, Inc.September 20, 2023

FDA 483 - Ajinomoto Althea, Inc. - September 20, 2023

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Record Details

Ajinomoto Althea, Inc. DBA Ajinomoto Bio-Pharma Services in San Diego, CA, was cited for significant deficiencies in microbial cross-contamination control and aseptic processing procedures. The inspection also found inadequate complaint investigations regarding particulate matter in finished drug products. These issues indicate a lack of robust quality control and adherence to sterile manufacturing practices.

Company: Ajinomoto Althea, Inc.
Inspection Date: September 20, 2023
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Cai-huan Qin, PhD, CSO
Yi Wang, PhD, Staff Fellow
Cassandra L. Abellard (investigator)

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ID · 189c64ec-06f0-442c-9aaf-eb9ea48f6a0b