# Virak Orthopedics LLC – FDA 483, Mar 27, 2026

Source: https://www.keypedia.com/records/483/virak-orthopedics-llc/50f2c47e-936f-4caa-a704-b87a4610c0bb

> FDA 483 for Virak Orthopedics LLC on March 27, 2026. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Virak Orthopedics LLC
- Inspection Date: 2026-03-27
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Virak Orthopedics LLC in Madison, NJ, a specification developer and repackager/relabeler, revealed two significant observations regarding their quality system. The firm failed to adequately document procedures for timely complaint handling and for reviewing the effectiveness of corrective actions. These deficiencies indicate a need for improved adherence to quality system regulations.

## Related Documents

- [483 - 2023-08-25](https://www.keypedia.com/records/483/virak-orthopedics-llc/8bedbd68-33f4-4377-9124-b3eeb682df1d) — date: August 25, 2023

## Related Officers

- [Jonathan Ho](https://www.keypedia.com/people/jonathan-ho/434f1c30-b660-4bc9-bc31-017366282edd)

Company: https://www.keypedia.com/companies/virak-orthopedics-llc/99cc3fdd-323c-4526-8f2c-5055ff58d90d

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248