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

During an FDA inspection conducted from August 1-4, 2022, Lingraphicare America, Inc., a medical device manufacturer based in Princeton, NJ, received a Form FDA 483 detailing four significant observations. The findings indicate areas of non-compliance with established quality system requirements. The main issues identified included a failure to maintain adequate Medical Device Reporting (MDR) procedures, specifically lacking electronic submission capabilities and a system for reporting serious incidents. Furthermore, the company had not established formal procedures for receiving, reviewing, and evaluating customer complaints, with existing complaint management processes missing critical details and specific complaint files lacking essential device identification such as model and serial numbers. An additional concern was the inadequate control of nonconforming products, as the relevant procedures lacked proper approval signatures and dates. These observations require Lingraphicare America, Inc. to undertake prompt corrective actions to ensure full adherence to the quality system regulations governing medical device manufacturing as outlined by the Federal Food, Drug, and Cosmetic Act. The firm is responsible for internally auditing and rectifying these identified deficiencies.