# FDA 483 - Links Medical Products Inc - October 18, 2023

Source: https://www.keypedia.com/records/483/links-medical-products-inc/0e85ee88-1e7b-45e5-af29-3321dba6bad8

> FDA 483 for Links Medical Products Inc on October 18, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Links Medical Products Inc
- Inspection Date: 2023-10-18
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Links Medical Products Inc, a manufacturer in Laguna Hills, CA, identified significant deficiencies in its corrective and preventive action (CAPA) procedures. The firm failed to adequately establish and follow its CAPA process, resulting in numerous overdue and unverified CAPAs. This indicates a breakdown in the quality system for addressing and preventing issues.

## Related Officers

- [Kevin N. Tran](https://www.keypedia.com/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.keypedia.com/companies/links-medical-products-inc/7eb84f2b-bf7b-4874-b74d-dfba668ab121

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6