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

Source: https://www.keypedia.com/records/483/henke-sass-wolf-of-americainc/50ac2223-2c4e-44a9-b68e-8534166574fa

> FDA 483 for Henke Sass Wolf Of America,Inc on September 16, 2025. Product: devices. 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: devices
- Summary: During an FDA inspection conducted from September 10 to September 16, 2025, Henke Sass Wolf Of America, Inc., a medical device contract manufacturer in Dudley, MA, received an FDA Form 483. The inspection identified a significant issue regarding the firm's quality system for accepting components. Specifically, the company lacked established procedures to ensure that salvaged goods, derived from medical devices and used in manufacturing finished products, met required specifications. An instance was cited where a medical device was manufactured and shipped utilizing a salvaged part without any documented acceptance activities to verify its suitability. This observation indicates a gap in the company's quality control processes for critical components. The FDA Form 483 highlights these objectionable conditions, emphasizing the firm's responsibility to conduct internal self-audits and implement corrective actions for all quality system violations. The company reportedly promised to correct the specific observation.

## Related Documents

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## 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