# FDA 483 - Fenwal International, Inc. - April 25, 2023

Source: https://www.globalkeysolutions.net/records/483/fenwal-international-inc/5f4657e4-6ed1-4f69-9447-bd7e983c624a

> FDA 483 for Fenwal International, Inc. on April 25, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fenwal International, Inc.
- Inspection Date: 2023-04-25
- Product Type: device
- Office Name: International Compliance Team
- Summary: Fenwal International, Inc., a medical device manufacturer in Bajos De Haina, Dominican Republic, was cited with seven observations during an FDA inspection from April 17-25, 2023. The inspection revealed significant deficiencies in quality system procedures, including inadequate control of non-conforming products, insufficient corrective and preventive actions, unsuitable building design for cleanroom operations, and poor equipment maintenance and process control. These issues indicate a systemic lack of adherence to quality system regulations for medical device manufacturing.

## Related Documents

- [WARNING_LETTER - 2019-09-26](https://www.globalkeysolutions.net/records/warning_letter/fenwal-international-inc/c5ed2a14-1350-4b12-b23a-b923fee66355)

## Related Officers

- [Scott T. Ballard](https://www.globalkeysolutions.net/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [Creighton T. Tuzon](https://www.globalkeysolutions.net/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)

Company: https://www.globalkeysolutions.net/companies/fenwal-international-inc/79f82b01-30b1-470b-8e6a-2d07c4452b48

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321