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

Source: https://www.globalkeysolutions.net/records/483/huestis-machine-corporation/60272864-0c98-42e8-8b79-f252ffeed002

> FDA 483 for Huestis Machine Corporation on June 30, 2022. Product: device. 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: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Huestis Machine Corporation, a medical device manufacturer in Bristol, RI, from June 15-30, 2022, revealed six significant deficiencies in its quality system. The observations included issues with product certification testing, design change procedures, corrective and preventive actions, complaint handling, medical device reporting, and software validation. Several of these findings were repeat observations, indicating persistent non-compliance with regulatory requirements.

## Related Documents

- [WARNING_LETTER - 2013-05-13](https://www.globalkeysolutions.net/records/warning_letter/huestis-machine-corporation/4c41b5d9-3f06-42dc-ad78-7bc062e474c4)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7