# FDA 483 - Specialty Vision Llc - July 07, 2022

Source: https://www.keypedia.com/records/483/specialty-vision-llc/da799e9e-5ee9-4b3d-853b-cc9066ffdd8e

> FDA 483 for Specialty Vision Llc on July 07, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Specialty Vision Llc
- Inspection Date: 2022-07-07
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Specialty Vision llc in Ridgefield Park, NJ, a dealer/retailer in contact lenses, revealed significant deficiencies in its quality system. The firm lacked established procedures for critical operations, failed to document acceptance of incoming products, and conducted uncontrolled rework of nonconforming items. These issues indicate a fundamental lack of control over product quality and compliance.

## Related Documents

- [483 - 2024-12-19](https://www.keypedia.com/records/483/specialty-vision-llc/23faf828-d709-4cfe-8aec-5307c0a13e70)

## Related Officers

- [David H. Smith](https://www.keypedia.com/people/david-h-smith/a78c3b20-1fb4-438f-904b-a6ab51a81945)

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

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