# FDA 483 - Ajinomoto Althea, Inc. - May 09, 2025

Source: https://www.keypedia.com/records/483/ajinomoto-althea-inc/460eb7ec-a1f2-489e-af6c-54a4f2adef31

> FDA 483 for Ajinomoto Althea, Inc. on May 09, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ajinomoto Althea, Inc.
- Inspection Date: 2025-05-09
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: Ajinomoto Althea, Inc., a sterile drug manufacturer in San Diego, CA, was cited for significant deficiencies during an FDA inspection. Observations included widespread poor aseptic practices, inadequate validation of sterilization processes, deficient cleaning and disinfection systems, and a failure to investigate unexplained discrepancies. Additionally, the quality control unit's procedures were not fully followed, and laboratory controls lacked scientifically sound test procedures.

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## Related Officers

- [Microbiologist](https://www.keypedia.com/people/michael-t-cyrus/30e497e1-2c17-4dd7-9a5b-251771cf4266)
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- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)
- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)

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

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b