# FDA 483 - Five Star Manufacturing, Inc. - August 29, 2025

Source: https://www.keypedia.com/records/483/five-star-manufacturing-inc/c2de2fbf-229d-4c31-89c8-d9535b32df9e

> FDA 483 for Five Star Manufacturing, Inc. on August 29, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Five Star Manufacturing, Inc.
- Inspection Date: 2025-08-29
- Product Type: other
- Office Name: New England District Office
- Summary: Five Star Manufacturing, Inc. in New Bedford, MA, received a Form FDA 483 with three observations related to its quality system. The inspection revealed deficiencies in the corrective and preventive action (CAPA) process, inadequate control of nonconforming product storage, and a lack of established records for acceptable suppliers. These issues indicate significant gaps in the firm's quality management system.

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/five-star-manufacturing-inc/95d559af-5f55-4c28-bb35-8b22617c9a4f

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