483
A.M. Surgical, Inc.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.
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ID · 8c8c98a6-a2c5-4bf5-bfc6-6cf0ecbb4f84