# FDA 483 - Ajinomoto Althea, Inc. - November 22, 2019

Source: https://www.globalkeysolutions.net/records/483/ajinomoto-althea-inc/b884498d-ac8b-47e8-93de-b6bcee3250b3

> FDA 483 for Ajinomoto Althea, Inc. on November 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ajinomoto Althea, Inc.
- Inspection Date: 2019-11-22
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Ajinomoto Althea, Inc. in San Diego, CA, was inspected regarding its sterile drug manufacturing operations. The inspection revealed significant deficiencies in aseptic process validation, batch failure investigations, data integrity for computer systems, and laboratory controls for sample management, indicating a moderate level of severity regarding GMP compliance.

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## Related Officers

- [Public Affairs Specialist](https://www.globalkeysolutions.net/people/joey-v-quitania/faae874f-94ea-4b63-89d1-649e60726f6f)
- [Laboratory Director](https://www.globalkeysolutions.net/people/jennifer-m-gogley/2025f306-80a6-4222-89ac-e4138028292a)
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Company: https://www.globalkeysolutions.net/companies/ajinomoto-althea-inc/75fb5ea8-b86f-45c1-946e-80c73765f544

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6