Sonomed, Inc.July 14, 2022

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

Record Details

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.

Company: Sonomed, Inc.
Inspection Date: July 14, 2022
Product Type: Device
Office: Division of Human and Animal Food Operations - East I
Person: Kwong P. Lee (investigator)

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ID · abb230e3-01b4-492e-b69d-6b519ca28253