483
Sonomed, Inc.Sonomed, Inc. – FDA 483, Jul 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.
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ID · abb230e3-01b4-492e-b69d-6b519ca28253
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