FDA 483 - Valeritas, Incorporated - September 07, 2018

During an inspection from August 21 to September 7, 2018, the FDA issued a Form 483 to Valeritas, Incorporated, a medical device manufacturer based in Marlborough, MA. The observations highlighted significant deficiencies in the company's quality system, primarily concerning medical device reporting (MDR) and complaint handling, under the Federal Food, Drug, and Cosmetic Act. Valeritas lacked written MDR procedures, maintained an inconsistent MDR log, and failed to submit 64 to 78 adverse event reports for its VGO Disposable Insulin Delivery Systems within the required 30-day timeframe, with some submissions delayed by 36 to 50 days. Additionally, many MEDWATCH entries were missing the date the firm received information. Further issues included inadequately maintained complaint files, with numerous complaints remaining open for extended periods of four to seven months without a defined timely processing procedure. Design risk analysis documentation contained conflicting assessments regarding potential device failures. Lastly, device history records did not adequately include or reference unique device identifiers (UDI) or universal product codes (UPC, relying on an uncontrolled 'sub DHR'. Valeritas is required to address these observations by implementing comprehensive corrective actions to ensure full compliance with medical device quality system regulations.