# FDA 483 - Euromed, Inc. - March 03, 2020

Source: https://www.keypedia.com/records/483/euromed-inc/007faba6-babe-438c-8bec-c5c0de92a069

> FDA 483 for Euromed, Inc. on March 03, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Euromed, Inc.
- Inspection Date: 2020-03-03
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Euromed, Inc. in Orangeburg, NY, a medical device manufacturer, was inspected by the FDA from February 26 to March 3, 2020. The inspection revealed significant deficiencies in quality system procedures, including a lack of internal quality audits, inadequate employee clothing requirements in cleanrooms, and poorly established procedures for in-process and finished device acceptance testing. These issues indicate a lack of robust quality control for sterile wound care dressings and adhesive tapes.

## Related Officers

- [Gregson A Joseph](https://www.keypedia.com/people/gregson-a-joseph/90bf8118-3f32-4f44-95c4-fcde1f741a18)

Company: https://www.keypedia.com/companies/euromed-inc/d99867cf-3611-4bb9-809b-080350b3e095

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