# FDA 483 - Huestis Machine Corporation - June 30, 2022

Source: https://www.keypedia.com/records/483/huestis-machine-corporation/3a10e39d-c423-4025-997e-591a41b9e9c2

> FDA 483 for Huestis Machine Corporation on June 30, 2022. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Huestis Machine Corporation
- Inspection Date: 2022-06-30
- Product Type: devices
- Office Name: New England District Office
- Summary: Huestis Machine Corporation received a Form FDA-483 following an inspection conducted from June 15 to June 30, 2022. The inspection revealed six significant observations concerning the company's manufacturing and quality system practices for medical devices. Key issues included a lack of robust certification processes, specifically noting discrepancies in X-ray peak energy values for collimators and insufficient testing of repaired devices. Procedures for design changes were found inadequate, with the company failing to properly document the impact, verification, and validation of modifications to collimator X-ray peak values. Both of these were repeat observations.

Furthermore, the firm's corrective and preventive action (CAPA) procedures were deemed deficient, failing to ensure timely processing, thorough investigations, and verification of action effectiveness. Complaint handling was also problematic, with numerous problem reports lacking documented investigations and Medical Device Reporting (MDR) evaluations, which was another repeat observation. The written MDR procedure itself was incomplete, lacking a comprehensive internal system for the timely identification, evaluation, and reporting of events to the FDA. Finally, software validation activities for electronic quality management and data processing systems were inadequately documented, marking a third repeat observation.

These findings indicate a need for Huestis Machine Corporation to enhance its adherence to good manufacturing practices and quality system requirements. The company is expected to address these observations by implementing and documenting effective corrective actions.

## Related Documents

- [WARNING_LETTER - 2013-05-13](https://www.keypedia.com/records/warning_letter/huestis-machine-corporation/4c41b5d9-3f06-42dc-ad78-7bc062e474c4)
- [483 - 2022-06-30](https://www.keypedia.com/records/483/huestis-machine-corporation/60272864-0c98-42e8-8b79-f252ffeed002)

## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/maryam-tabatabaie-investigator/6a7d594c-ab2d-4890-9e7c-56478c39f888)

Company: https://www.keypedia.com/companies/huestis-machine-corporation/744c0dee-8cae-4284-aee1-cf970bbbcdb7

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