# FDA 483 - Anschel Technology Inc. - December 31, 2019

Source: https://www.keypedia.com/records/483/anschel-technology-inc/195397db-c364-49ac-9efc-f4efa97c4f6a

> FDA 483 for Anschel Technology Inc. on December 31, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Anschel Technology Inc.
- Inspection Date: 2019-12-31
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Anschel Technology Inc. in Rocky Point, NY, a medical device specification setter, was inspected by the FDA from December 19-31, 2019. The inspection revealed two significant issues: a lack of maintained written electronic Medical Device Reporting (eMDR) procedures and deficiencies in device history records regarding Unique Device Identifiers (UDI) for their Class II medical devices. These observations indicate a need for improved quality system compliance.

## Related Officers

- [investigator](https://www.keypedia.com/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.keypedia.com/companies/anschel-technology-inc/df5fe7d8-1632-4dcd-97d2-58af44c7e298

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