# FDA 483 - Surgical Design Corp - January 30, 2020

Source: https://www.keypedia.com/records/483/surgical-design-corp/3dc33423-77c3-47a1-8f7c-b2e6928c4d88

> FDA 483 for Surgical Design Corp on January 30, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Surgical Design Corp
- Inspection Date: 2020-01-30
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Surgical Design Corp, a distributor located in Armonk, NY, underwent an FDA inspection that identified two significant observations. The firm failed to maintain adequate complaint files and lacked a written complaint handling procedure. Additionally, the company did not clearly define control over its suppliers and contractors, specifically lacking written quality agreements with its product distributor.

## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.keypedia.com/companies/surgical-design-corp/45da6606-0f11-4c72-bc2a-c7bafe40fa6c

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