# FDA 483 - Henke Sass Wolf Of America,Inc - September 16, 2025

Source: https://www.keypedia.com/records/483/henke-sass-wolf-of-americainc/4f7ed0d3-930e-400f-9d52-ab56061bfa1f

> FDA 483 for Henke Sass Wolf Of America,Inc on September 16, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Henke Sass Wolf Of America,Inc
- Inspection Date: 2025-09-16
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of Henke Sass Wolf Of America, Inc in Dudley, MA, conducted from September 10-16, 2025, identified one observation. The firm lacked established procedures for acceptance activities, specifically for salvaged medical device goods used in manufacturing. This indicates a potential deficiency in ensuring component quality and adherence to specifications.

## Related Documents

- [483 - 2025-09-16](https://www.keypedia.com/records/483/henke-sass-wolf-of-americainc/50ac2223-2c4e-44a9-b68e-8534166574fa)

## Related Officers

- [Eric C. Schmitt](https://www.keypedia.com/people/eric-c-schmitt/f2716c8c-f06e-4519-a1e7-63a3ef6e07fb)

Company: https://www.keypedia.com/companies/henke-sass-wolf-of-americainc/fd8be98b-7480-48c1-bf7d-b51aba678e72

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