FDA EIR - Paragon BioTeck Inc - September 25, 2019

Paragon BioTeck Inc., a manufacturer of the Comfortear® Lacrisolve® Absorbable Puncture Plugs, underwent an abbreviated FDA Quality System Inspection Technique (QSIT) inspection from September 24-25, 2019. This inspection, conducted under Compliance Program 7382.845 for medical device manufacturers, focused on evaluating Management Controls, Design Controls, Corrective and Preventive Action (CAPA), and Purchasing Controls, alongside Unique Device Identifier (UDI) requirements. Despite the inspection being classified as No Action Indicated (NAI) with no FDA-483 form issued, the investigator identified notable deficiencies. The primary issues observed were the firm's failure to adequately document investigations pertaining to customer complaints within their complaint records and a similar lack of documentation for investigations related to Corrective and Preventive Actions within their CAPA records. During the close-out meeting, company management acknowledged these observations and committed to implementing necessary corrections to meet regulatory standards. The FDA investigator reinforced the firm's responsibility for continuous internal self-audits to proactively identify and rectify any quality system deficiencies, advising that voluntary correction is essential to avoid potential future regulatory enforcement actions.