# FDA 483 - Ajinomoto Althea, Inc. - March 18, 2019

Source: https://www.keypedia.com/records/483/ajinomoto-althea-inc/278c5bc4-34fe-420e-8580-fda83cf0faf4

> FDA 483 for Ajinomoto Althea, Inc. on March 18, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ajinomoto Althea, Inc.
- Inspection Date: 2019-03-18
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Ajinomoto Althea, Inc. in San Diego, CA, a drug manufacturer, revealed three observations. The firm was cited for inadequate deviation investigations regarding broken vials, a lack of quality control unit oversight due to an unclear quality agreement, and a failure to perform required clean hold time studies and cleaning validation.

## Related Documents

- [EIR - 2019-08-07](https://www.keypedia.com/records/eir/ajinomoto-althea-inc/112ce0ca-fbe9-4c70-8b5c-e856206bb982)
- [483 - 2023-01-16](https://www.keypedia.com/records/483/ajinomoto-althea-inc/31d386f5-e5ea-4cf9-b563-54c74ade61ef)
- [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)

## Related Officers

- [investigator](https://www.keypedia.com/people/ashley-queen/8a53ebd7-95a4-4403-b853-ba0ebf3e973b)
- [Team Biologics Staff](https://www.keypedia.com/people/linda-thai/f4d9a1c3-e5e8-4f13-8abe-e1f1e597c8f8)
- [ Investigator, Consumer Safety Officer](https://www.keypedia.com/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)

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

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321