# FDA 483 - Ajinomoto Althea, Inc. - May 18, 2015

Source: https://www.globalkeysolutions.net/records/483/ajinomoto-althea-inc/79794473-afa0-42d4-89c0-6167c71ad994

> FDA 483 for Ajinomoto Althea, Inc. on May 18, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ajinomoto Althea, Inc.
- Inspection Date: 2015-05-18
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Ajinomoto Althea, Inc. in San Diego, CA, a sterile drug manufacturer, was inspected from May 6-18, 2015. The inspection revealed deficiencies in written procedures for preventing microbiological contamination during sterile drug product transfer and in the validation of component supplier test results for bioprocessing bags. These issues indicate a moderate level of concern regarding sterility assurance and quality control.

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## Related Officers

- [Public Affairs Specialist](https://www.globalkeysolutions.net/people/joey-v-quitania/faae874f-94ea-4b63-89d1-649e60726f6f)

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