# FDA 483 - Brain Scientific Inc - July 03, 2019

Source: https://www.globalkeysolutions.net/records/483/brain-scientific-inc/940c9482-4013-4022-be38-7aad24967675

> FDA 483 for Brain Scientific Inc on July 03, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brain Scientific Inc
- Inspection Date: 2019-07-03
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Memory MD, Inc., a medical device manufacturer in New York, NY, was inspected by the FDA from June 27 to July 3, 2019. The inspection revealed significant deficiencies in design control documentation, including inadequate validation results and missing design review records. Additionally, the firm failed to adequately maintain device history records, specifically regarding incoming inspection forms.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/brain-scientific-inc/f10f20fb-82fe-4415-8aae-b90ab98b7b9f

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