FDA 483 - The Morel Company, LLC - November 01, 2018

The FDA conducted an inspection of The Morel Company, LLC, a medical device manufacturer, from October 30 to November 1, 2018. The inspection resulted in the issuance of a Form FDA 483, identifying one significant observation related to quality system requirements.The primary issue noted was the inadequacy of the company's procedures for handling reworked nonconforming products. Specifically, the Production and Process Controls Standard Operating Procedure, dated September 10, 2015, failed to ensure that adverse impact assessments for rework and re-evaluation activities were documented in the device history records. A review of four device history records involving rework revealed that three lacked these critical documented assessments. This deficiency was identified as a repeat observation from a previous inspection, highlighting a persistent quality system gap.This observation falls under the Federal Food, Drug, and Cosmetic Act, which mandates medical device manufacturers maintain robust quality systems. While the FDA 483 itself is not a final determination of non-compliance, it requires the company to take prompt corrective action to address the identified issues. The company reportedly "promised to correct" the noted observation, indicating an understanding of the need to revise procedures and ensure proper documentation for all product rework activities to prevent recurrence and ensure product quality and safety.