New England Ortho Laboratory, Inc. – FDA 483, Feb 18, 2022

New England Ortho Laboratory, Inc. in Andover, MA, a manufacturer of medical devices, was cited for several deficiencies during an FDA inspection. Observations included inadequate documentation of device history records, lack of documented equipment maintenance, and failure to perform and document quality audits and management reviews. These issues indicate a lack of adherence to established quality system procedures.