Novum Medical Products Cited for Insufficient Records

The FDA hit Novum Medical Products with a Form 483 after it observed insufficient device master records at its Amherst, New York facility.

The device master record for a hospital crib product failed to include or refer to the location of its production procedures, quality assurance procedures or packaging and label specs.

One of the firm’s device history records lacked unique device identifier labels applied to the firm’s hospital crib products.