# FDA 483 - Sonomed, Inc. - July 14, 2022

Source: https://www.globalkeysolutions.net/records/483/sonomed-inc/abb230e3-01b4-492e-b69d-6b519ca28253

> FDA 483 for Sonomed, Inc. on July 14, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sonomed, Inc.
- Inspection Date: 2022-07-14
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Sonomed, Inc., a medical device manufacturer in New Hyde Park, NY, revealed two observations related to inadequate record-keeping. The firm failed to adequately maintain its device master record and its device history record, indicating deficiencies in their quality system.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/sonomed-inc/d8f53ba0-e6f4-408f-8bc2-0c8281eb6c8a

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