# FDA 483 - Q Urological - March 16, 2020

Source: https://www.globalkeysolutions.net/records/483/q-urological/865ecb1a-8f57-4401-9293-d0f5fe63f709

> FDA 483 for Q Urological on March 16, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Q Urological
- Inspection Date: 2020-03-16
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Q Urological in Medfield, MA, a medical device manufacturer, revealed significant deficiencies across its quality system. The firm failed to adequately establish procedures for corrective and preventive actions, complaint handling, management review, and quality audits. These findings indicate a systemic lack of control over critical quality processes.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.globalkeysolutions.net/companies/q-urological/d76097ab-2093-496d-a9ce-88c33e216287

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