# Pensar Medical LLC – FDA 483, Apr 28, 2026

Source: https://www.keypedia.com/records/483/pensar-medical-llc/fb9c331b-b6f1-453b-9d3a-4ccb43234f8c

> FDA 483 for Pensar Medical LLC on April 28, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pensar Medical LLC
- Inspection Date: 2026-04-28
- Product Type: device
- Office Name: Dallas District Office
- Summary: Pensar Medical LLC, a medical device specification developer in Houston, TX, received seven observations during an FDA inspection. The firm demonstrated significant deficiencies across its quality management system, particularly in risk management, design control, medical device reporting, complaint handling, and corrective and preventive actions. These issues indicate a systemic failure to adequately implement procedures crucial for ensuring device safety and effectiveness.

## Related Documents

- [WARNING_LETTER - 2026-04-28](https://www.keypedia.com/records/warning_letter/pensar-medical-llc/d70e6750-11f3-422d-89b9-3880433c9461) — date: April 28, 2026
- [483 - 2023-02-16](https://www.keypedia.com/records/483/pensar-medical-llc/19e72f4e-da63-4495-a2d2-b07b3f2430df) — date: February 16, 2023

## Related Officers

- [Jocelyn C. Turner](https://www.keypedia.com/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.keypedia.com/companies/pensar-medical-llc/20c490ed-40f5-4b49-9d82-e6add73017bb

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9