FDA 483 - Lingraphicare America, Inc. - August 04, 2022

An FDA inspection of Lingraphicare America, Inc. in Princeton, NJ, a medical device manufacturer, revealed significant deficiencies in their quality system. Observations included a lack of maintained written procedures for Medical Device Reporting, unestablished procedures for complaint handling, inadequate maintenance of complaint files, and deficiencies in nonconforming product procedures.