# FDA 483 - Ajinomoto Althea, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/ajinomoto-althea-inc/14182454-6acc-47ab-81b0-40a428eed662

> FDA 483 for Ajinomoto Althea, Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ajinomoto Althea, Inc.
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Ajinomoto Bio-Pharma Service (Ajinomoto Althea Inc.) in San Diego, CA, revealed significant deficiencies in aseptic processing and equipment maintenance. Inspectors observed operators failing to follow aseptic techniques, inadequate environmental monitoring procedures, and unclean equipment. These issues pose a risk to the sterility and quality of drug products manufactured at the facility.

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## Related Officers

- [Virginia A. Carroll](https://www.keypedia.com/people/virginia-a-carroll/180e8c1a-1712-4701-9399-9758573ef8d8)
- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)
- [https://www.fda.gov/media/120628/download](https://www.keypedia.com/people/santiago-gallardo-johnson/f5086b0c-c8fc-44dd-8d12-6506b9dd313f)

Company: https://www.keypedia.com/companies/ajinomoto-althea-inc/75fb5ea8-b86f-45c1-946e-80c73765f544

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd