# FDA 483 - Specialty Vision Llc - December 19, 2024

Source: https://www.globalkeysolutions.net/records/483/specialty-vision-llc/23faf828-d709-4cfe-8aec-5307c0a13e70

> FDA 483 for Specialty Vision Llc on December 19, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Specialty Vision Llc
- Inspection Date: 2024-12-19
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Specialty Vision llc in Ridgefield Park, NJ, a dealer/retailer of contact lenses, revealed significant deficiencies in its quality system. The firm failed to establish essential procedures for its quality system, including management responsibility, supplier control, CAPA, and complaint handling. Additionally, acceptance activities for incoming products were not documented, and procedures for the rework of nonconforming products were not adequately established.

## Related Documents

- [483 - 2022-07-07](https://www.globalkeysolutions.net/records/483/specialty-vision-llc/da799e9e-5ee9-4b3d-853b-cc9066ffdd8e)

## Related Officers

- [Esteban Beltran](https://www.globalkeysolutions.net/people/esteban-beltran/9a9bf6b2-ecdf-494c-82f4-5ef5932d629a)

Company: https://www.globalkeysolutions.net/companies/specialty-vision-llc/0c61d4ea-8225-445f-8273-7f0d3c9bf6b4

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