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

Source: https://www.globalkeysolutions.net/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.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/ashley-queen/8a53ebd7-95a4-4403-b853-ba0ebf3e973b)
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Company: https://www.globalkeysolutions.net/companies/ajinomoto-althea-inc/75fb5ea8-b86f-45c1-946e-80c73765f544

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