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483
•A.M. Surgical, Inc.•October 20, 2023

FDA 483 - A.M. Surgical, Inc. - October 20, 2023

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Record Details

A.M. Surgical, Inc., a medical device manufacturer in Smithtown, NY, received a Form FDA 483 with one observation. The inspection revealed that the firm's device master record was not adequately maintained. Specifically, it lacked the identification of materials used for manufacturing the devices.

Company
A.M. Surgical, Inc.
Inspection Date
October 20, 2023
Product Type
Device
Office
Division of Human and Animal Food Operations - East I
Person
  • Kwong P. Lee (investigator)
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ID · 8c8c98a6-a2c5-4bf5-bfc6-6cf0ecbb4f84

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