# FDA 483 - Ajinomoto Althea, Inc. - August 07, 2019

Source: https://www.keypedia.com/records/483/ajinomoto-althea-inc/f4a2b512-1b50-4605-a609-304be78baf30

> FDA 483 for Ajinomoto Althea, Inc. on August 07, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ajinomoto Althea, Inc.
- Inspection Date: 2019-08-07
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Ajinomoto Althea, Inc. in San Diego, CA, a sterile drug manufacturer, was cited for two significant issues. The firm's quality control unit failed to consistently reject drug product lots contaminated with stainless steel corrosion particulates. Additionally, investigations into discrepancies and batch failures did not always extend to other potentially affected batches or drug products.

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## Related Officers

- [https://www.fda.gov/media/120628/download](https://www.keypedia.com/people/santiago-gallardo-johnson/f5086b0c-c8fc-44dd-8d12-6506b9dd313f)
- [Public Affairs Specialist](https://www.keypedia.com/people/joey-v-quitania/faae874f-94ea-4b63-89d1-649e60726f6f)

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

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