# FDA 483 - W.A. Baum Co. Inc. - June 16, 2021

Source: https://www.keypedia.com/records/483/wa-baum-co-inc/cf661f06-09c7-43c1-a762-6589b9dde84d

> FDA 483 for W.A. Baum Co. Inc. on June 16, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: W.A. Baum Co. Inc.
- Inspection Date: 2021-06-16
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Baum, W A Co. Inc., a medical device manufacturer in Copiague, NY, was inspected by the FDA from June 14-16, 2021. The inspection revealed a significant issue regarding the firm's failure to maintain written Medical Device Reporting (MDR) procedures. Specifically, the company lacked an electronic MDR procedure and an Electronic Submissions Gateway account for reporting serious injuries and deaths.

## Related Documents

- [483 - 2023-11-06](https://www.keypedia.com/records/483/wa-baum-co-inc/9856e055-9125-40e3-b863-3f1f5e4938b6)

## Related Officers

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

Company: https://www.keypedia.com/companies/wa-baum-co-inc/79dd9691-50ad-4eb7-ab3c-559193601298

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