# FDA 483 - Ajinomoto Althea, Inc. - April 06, 2017

Source: https://www.keypedia.com/records/483/ajinomoto-althea-inc/4b7b30a0-9746-4732-ad04-a17999995100

> FDA 483 for Ajinomoto Althea, Inc. on April 06, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ajinomoto Althea, Inc.
- Inspection Date: 2017-04-06
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Ajinomoto Althea, Inc., a sterile drug manufacturer in San Diego, CA, revealed significant deficiencies in their quality control and manufacturing operations. Observations included inadequate written procedures for cleaning and maintenance, unapproved laboratory control mechanisms, and a failure to follow established laboratory protocols. These issues indicate a need for improved oversight and adherence to good manufacturing practices.

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## Related Officers

- [Lata C. Mathew](https://www.keypedia.com/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)
- [Director of Investigations Branch](https://www.keypedia.com/people/katherine-e-jacobitz/9a713b44-95c4-43a2-83bb-8d30062d8345)

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