# FDA EIR - Ajinomoto Company Inc. - November 05, 2019

Source: https://www.keypedia.com/records/eir/ajinomoto-company-inc/8a978076-f62e-4e9b-b222-f1a73068fc1b

> FDA EIR for Ajinomoto Company Inc. on November 05, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Ajinomoto Company Inc.
- Inspection Date: 2019-11-05
- Product Type: Drugs
- Office Name: Food and Drug Administration
- Summary: An FDA inspection of Ajinomoto Company Inc.'s Kawasaki Plant, a non-sterile Active Pharmaceutical Ingredient (API) manufacturer, was conducted from November 5 to November 8, 2019. This abbreviated Good Manufacturing Practice (GMP) inspection, performed under Compliance Program 7356.002F for API Process Inspection, focused on several high-volume products exported to the U.S. and covered the Quality, Production, and partial Laboratory Control Systems. While the inspection concluded with a "No Action Indicated" (NAI) classification and no official Form FDA-483 observations were issued, several deficiencies were discussed verbally with the firm. These included inadequate investigations into Out-of-Specification results (though not cited for lots supplied only to non-U.S. markets), a water puddle observed in a Class 100,000 cleanroom, and insufficient process validation procedures. The firm is expected to address these verbal observations, and a re-inspection is planned based on a CDER risk assessment.

## Related Documents

- [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)

## Related Officers

- [Jogy George](https://www.keypedia.com/people/jogy-george/00ef0915-66d2-4b34-9b74-d1e08caf2db3)
- [company_representative](https://www.keypedia.com/people/kazuyuki-kubota/2f9e196a-7d7c-4330-88e2-d5cb606252b0)
- [Deputy District Director](https://www.keypedia.com/people/craig-w-swanson/7fddeef9-fb53-48ba-afc2-80e15d7f777f)
- [issuing_officer](https://www.keypedia.com/people/stephen-j-mottola/a35bf779-9edb-40a3-93c8-1ac43808dccf)
- [company_representative](https://www.keypedia.com/people/andrew-lagrange/d5b77450-bc22-454a-a15b-720d265f824d)

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

Office: https://www.keypedia.com/offices/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516