Adroit Medical Hit for Recordkeeping

September 15, 2017

The FDA issued a Form 483 to Adroit Medical Systems for its recordkeeping and device history record procedures.

The agency issued the form following a July inspection of the devicemaker’s Loudon, Tenn., facility.

The agency said the firm’s device history record did not indicate that its class II heat therapy pump was manufactured according to the device master record.

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