# FDA 483 - O&M HALYARD INC - April 27, 2023

Source: https://www.keypedia.com/records/483/om-halyard-inc/e33128e9-7dcc-4c8c-8373-5f530615fac1

> FDA 483 for O&M HALYARD INC on April 27, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: O&M HALYARD INC
- Inspection Date: 2023-04-27
- Product Type: device
- Office Name: Atlanta District Office
- Summary: O&M HALYARD INC in Alpharetta, GA, a medical device specification developer, was cited for failing to submit Medical Device Reports (MDRs) in a timely manner. The firm did not report multiple complaints regarding N95 Respirator elastic bands breaking during use, which could lead to serious injury if the malfunction were to recur, potentially exposing healthcare workers to COVID-19.

## Related Officers

- [Miaja Umaedi](https://www.keypedia.com/people/miaja-umaedi/0a41661f-08bb-4523-ab09-b17e230068e0)

Company: https://www.keypedia.com/companies/om-halyard-inc/c2f4f8cd-f63b-4591-81f3-26717b6d3944

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7