# FDA 483 - Fenwal International, Inc. - February 05, 2026

Source: https://www.keypedia.com/records/483/fenwal-international-inc/dabdcd96-fd39-4c1d-a897-beca575c9750

> FDA 483 for Fenwal International, Inc. on February 05, 2026. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fenwal International, Inc.
- Inspection Date: 2026-02-05
- Product Type: other
- Office Name: San Juan District Office
- Summary: An FDA inspection of Fenwal International, Inc. in Maricao, PR, revealed significant deficiencies in their manufacturing operations, particularly concerning production and process controls, quality unit oversight, and facility maintenance. The firm released products with out-of-specification bioburden and failed to adequately investigate contamination issues, indicating a systemic lack of adherence to established quality standards. Many of these issues were repeat observations from previous inspections, highlighting persistent problems.

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- [483 - 2024-09-18](https://www.keypedia.com/records/483/fenwal-international-inc/9da39e05-129f-4655-9b84-85216d00b812)

## Related Officers

- [Scott T. Ballard](https://www.keypedia.com/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [Ramon L. Gonzalez-Prieto](https://www.keypedia.com/people/ramon-l-gonzalez-prieto/f03487d2-7c8c-407f-8270-a838f7a7d127)

Company: https://www.keypedia.com/companies/fenwal-international-inc/f7736da8-9a5b-421a-8f73-803b3504d456

Office: https://www.keypedia.com/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8