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

Source: https://www.keypedia.com/records/483/ajinomoto-althea-inc/31d386f5-e5ea-4cf9-b563-54c74ade61ef

> FDA 483 for Ajinomoto Althea, Inc. on January 16, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ajinomoto Althea, Inc.
- Inspection Date: 2023-01-16
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Documents

- [EIR - 2019-08-07](https://www.keypedia.com/records/eir/ajinomoto-althea-inc/112ce0ca-fbe9-4c70-8b5c-e856206bb982)
- [483 - 2019-08-07](https://www.keypedia.com/records/483/ajinomoto-althea-inc/f4a2b512-1b50-4605-a609-304be78baf30)
- [483 - 2019-02-07](https://www.keypedia.com/records/483/ajinomoto-althea-inc/e1378dd5-40d2-4f08-91f2-466a36441ce1)
- [483 - 2015-05-18](https://www.keypedia.com/records/483/ajinomoto-althea-inc/79794473-afa0-42d4-89c0-6167c71ad994)
- [483 - 2025-05-09](https://www.keypedia.com/records/483/ajinomoto-althea-inc/460eb7ec-a1f2-489e-af6c-54a4f2adef31)

## Related Officers

- [Regulatory Scientist at FDA](https://www.keypedia.com/people/yi-wang/f5355ae0-ae28-452f-829a-786b7ebc4791)
- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)
- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

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