# FDA 483 - Miyoshi America, Inc - January 13, 2023

Source: https://www.globalkeysolutions.net/records/483/miyoshi-america-inc/804d29f6-1061-4616-98b0-4c313616829d

> FDA 483 for Miyoshi America, Inc on January 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Miyoshi America, Inc
- Inspection Date: 2023-01-13
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Miyoshi America, Inc. in Dayville, CT, an API manufacturer, was cited for three significant issues during an FDA inspection. The firm failed to establish adequate cleaning procedures to prevent cross-contamination, lacked sufficient control over computerized lab systems to prevent data deletion, and did not maintain complete laboratory control records for API release testing. These observations indicate deficiencies in quality control and data integrity practices.

## Related Documents

- [483 - 2021-05-25](https://www.globalkeysolutions.net/records/483/miyoshi-america-inc/ca07a1a9-e443-43d4-ae69-8ffd6fadd238)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/pushpa-s-jayasekara/cfd7d22f-b4c2-4002-ae18-b5435815d27d)
- [Samir C. Gala, Investigator](https://www.globalkeysolutions.net/people/samir-c-gala-investigator/c9fccccd-78d4-4ccb-a7f4-10ad8a87b45f)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7