# Gentuity, LLC – FDA 483, Mar 5, 2026

Source: https://www.keypedia.com/records/483/gentuity-llc/335a4748-7205-4a78-8fd7-9f342998b3e4

> FDA 483 for Gentuity, LLC on March 05, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gentuity, LLC
- Inspection Date: 2026-03-05
- Product Type: device
- Office Name: New England District Office
- Summary: Gentuity, LLC in Sudbury, MA, received a Form FDA 483 with seven observations detailing significant quality system deficiencies. The inspection revealed failures in reporting field actions, inadequate corrective and preventive actions, and insufficient design control validation for software and device components. Additionally, the firm demonstrated poor complaint handling, flawed supplier evaluation, inadequate incoming product verification, and systematic underestimation of risks in their risk management activities, indicating a severe lack of control over critical medical device processes.

## Related Officers

- [Sunita Pandey](https://www.keypedia.com/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)

Company: https://www.keypedia.com/companies/gentuity-llc/bc756f97-e3e4-4eac-8be2-9773d64a3f42

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