# FDA EIR - Ajinomoto Company Inc. - November 08, 2019

Source: https://www.keypedia.com/records/eir/ajinomoto-company-inc/7a24a9bd-4325-4553-b2c7-62f9ada05ba7

> FDA EIR for Ajinomoto Company Inc. on November 08, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Ajinomoto Company Inc.
- Inspection Date: 2019-11-08
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: The U.S. Food and Drug Administration conducted an abbreviated Good Manufacturing Practice (GMP) inspection of Ajinomoto Company Inc.'s Kawasaki Plant in Japan from November 5 to November 8, 2019. This inspection, guided by Compliance Program 7356.002F for Active Pharmaceutical Ingredients (APIs), assessed the firm's quality, production, and laboratory control systems for high-volume products exported to the USA. While no formal Form FDA-483 (Inspectional Observations) was issued, the inspection identified and verbally discussed several deficiencies. These included inadequate investigations into Out-of-Specification (OOS) results (though not cited for lots supplied to non-U.S. markets), the presence of a water puddle in a Class 100,000 room, and inadequate process validation procedures. The inspection concluded with a "No Action Indicated" classification, meaning no immediate formal regulatory action was required. However, the FDA recommended a re-inspection based on a CDER risk assessment, indicating continued regulatory oversight and the expectation for the company to address the identified issues internally.

## Related Documents

- [EIR - 2019-11-05](https://www.keypedia.com/records/eir/ajinomoto-company-inc/8a978076-f62e-4e9b-b222-f1a73068fc1b)
- [EIR - 2019-11-08](https://www.keypedia.com/records/eir/ajinomoto-company-inc/bca20f82-a988-46e5-82f6-ba626e7c3443)
- [483 - 2025-02-21](https://www.keypedia.com/records/483/ajinomoto-company-inc/c7697083-0d35-48c4-b56a-9c16507a4735)
- [483 - 2025-02-17](https://www.keypedia.com/records/483/ajinomoto-company-inc/476b776a-5bbc-4d29-9483-83e58389fbdf)
- [483 - 2025-02-21](https://www.keypedia.com/records/483/ajinomoto-company-inc/3bb65a8d-3705-45ab-943d-7c4237edf495)

## Related Officers

- [Jogy George](https://www.keypedia.com/people/jogy-george/00ef0915-66d2-4b34-9b74-d1e08caf2db3)
- [issuing_officer](https://www.keypedia.com/people/stephen-j-mottola/a35bf779-9edb-40a3-93c8-1ac43808dccf)

Company: https://www.keypedia.com/companies/ajinomoto-company-inc/f1a6a55e-d3b0-4a4e-b3ca-9858a9ca10b6

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64