# FDA 483 - Vee international inc - July 15, 2022

Source: https://www.keypedia.com/records/483/vee-international-inc/8c4862b0-ab45-434c-bfd1-8bcba6f4b0e4

> FDA 483 for Vee international inc on July 15, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vee international inc
- Inspection Date: 2022-07-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Vee international inc in Garden City, NY, an importer of penile erection rigidity devices, revealed significant deficiencies in their quality system. The firm failed to perform adequate risk analysis and document design input requirements for their Class II medical devices. Additionally, there was no agreement with foreign suppliers to notify the firm of product or service changes.

## Related Officers

- [Jacqueline S. Warner](https://www.keypedia.com/people/jacqueline-s-warner/d001f4ec-db46-4d78-a5dd-efea7ddfb893)

Company: https://www.keypedia.com/companies/vee-international-inc/b984e121-e073-49c4-825b-9888e9c8d686

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961