# FDA 483 - Miyoshi America, Inc - February 06, 2026

Source: https://www.keypedia.com/records/483/miyoshi-america-inc/03e73d7b-d872-4aff-b0b1-c9d1892c555d

> FDA 483 for Miyoshi America, Inc on February 06, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Miyoshi America, Inc
- Inspection Date: 2026-02-06
- Product Type: drugs
- Office Name: New England District Office
- Summary: An FDA inspection of Miyoshi America, Inc., an API manufacturer in Danville, CT, revealed significant deficiencies in quality control. Observations included a failure to validate test methods and qualify reference standards, an inadequate supplier qualification program, and a quality unit that did not ensure CGMP compliance regarding waste management. Additionally, the firm's training program for laboratory personnel was found to be insufficient.

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## Related Officers

- [Drug Investigator](https://www.keypedia.com/people/samir-c-gala/904c34ee-013d-4663-a87a-9cbdbcf2b40e)
- [Luxuly Abraham](https://www.keypedia.com/people/luxuly-abraham/d33e3164-ec89-488b-bab9-a9ec30544970)
- [Alisha B. Patel](https://www.keypedia.com/people/alisha-b-patel/3c106dac-0e0d-41f2-9f7a-69982d4e6579)

Company: https://www.keypedia.com/companies/miyoshi-america-inc/b8b68045-2f79-4dab-a8b0-08e43de931cb

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144