# FDA 483 - W.A. Baum Co. Inc. - November 06, 2023

Source: https://www.globalkeysolutions.net/records/483/wa-baum-co-inc/9856e055-9125-40e3-b863-3f1f5e4938b6

> FDA 483 for W.A. Baum Co. Inc. on November 06, 2023. 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: 2023-11-06
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of W.A. Baum Co. Inc., a medical device manufacturer in Copiague, NY, identified three significant observations. The firm failed to maintain adequate written procedures for Medical Device Reporting (MDR) and did not establish sufficient requirements for suppliers. Additionally, corrective and preventive action activities, specifically rework documentation, were found to be inadequate.

## Related Documents

- [483 - 2021-06-16](https://www.globalkeysolutions.net/records/483/wa-baum-co-inc/cf661f06-09c7-43c1-a762-6589b9dde84d)

## Related Officers

- [Andrew J. Garufi](https://www.globalkeysolutions.net/people/andrew-j-garufi/567f6aaa-f6f2-45a3-9a58-80b33f3ad021)

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

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