# FDA 483 - Miyoshi America, Inc - May 25, 2021

Source: https://www.keypedia.com/records/483/miyoshi-america-inc/ca07a1a9-e443-43d4-ae69-8ffd6fadd238

> FDA 483 for Miyoshi America, Inc on May 25, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Miyoshi America, Inc
- Inspection Date: 2021-05-25
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Miyoshi America, Inc., an API manufacturer in Dayville, Connecticut, revealed significant deficiencies across its quality, facilities, production, and laboratory systems. Key issues included inadequate investigations into product failures, untimely corrective actions, insufficient cleaning procedures, and a deficient preventative maintenance program. The firm also failed to adequately validate rework processes and maintain complete and secure laboratory control records, raising concerns about data integrity and product quality.

## Related Documents

- [483 - 2023-01-13](https://www.keypedia.com/records/483/miyoshi-america-inc/804d29f6-1061-4616-98b0-4c313616829d)

## Related Officers

- [Regional Manager](https://www.keypedia.com/people/jonah-s-ufferfilge/6bcd2028-9aca-4704-bd7b-c835874fad9d)
- [Drug Investigator](https://www.keypedia.com/people/samir-c-gala/904c34ee-013d-4663-a87a-9cbdbcf2b40e)

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

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94