FDA 483 - Spectronics Corp - January 30, 2020

Spectronics Corp, a medical device manufacturer in Westbury, NY, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included the lack of written Medical Device Reporting procedures, inadequate device master records with missing test limits, and multiple issues with device history records, such as missing test results, work order numbers, use of white-out, and absence of unique device identifiers. These findings indicate a failure to maintain proper documentation and reporting practices for medical devices.