# Virak Orthopedics LLC – FDA 483, Aug 25, 2023

Source: https://www.keypedia.com/records/483/virak-orthopedics-llc/8bedbd68-33f4-4377-9124-b3eeb682df1d

> FDA 483 for Virak Orthopedics LLC on August 25, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Virak Orthopedics LLC
- Inspection Date: 2023-08-25
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Virak Orthopedics LLC, a packer and distributor, was cited with two observations during an FDA inspection. The firm failed to adequately re-evaluate suppliers according to its established procedures. Additionally, internal quality audits were not performed as required by the firm's own SOPs, with the last audit dating back to 2017.

## Related Documents

- [483 - 2026-03-27](https://www.keypedia.com/records/483/virak-orthopedics-llc/50f2c47e-936f-4caa-a704-b87a4610c0bb) — date: March 27, 2026

## Related Officers

- [Monica L. Gutierrez](https://www.keypedia.com/people/monica-l-gutierrez/fe60f8c6-ad1b-4619-9903-ed7be6d3bf7d)

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