FDA EIR - 180 Innovations LLC - January 29, 2020

An FDA routine-surveillance inspection of 180 Innovations LLC, a medical device repackager/relabeler in Lakewood, CO, was conducted from January 28-29, 2020. The inspection, guided by the Quality System Inspectional Technique (QSIT), focused on the company's Corrective and Preventive Actions (CAPA) and Production and Process Controls, as they handle Class II medical devices like digital clinical thermometers. The inspection identified four significant deficiencies, leading to the issuance of an FDA Form 483. Main violations included inadequate procedures for receiving, reviewing, and evaluating customer complaints, specifically lacking proper documentation of failure investigations. The company also failed to adequately establish procedures for reworking nonconforming products, with one reviewed rework event entirely undocumented. Furthermore, procedures for identifying valid statistical techniques for process capability and product characteristics were not established, resulting in inconsistencies in product acceptance sampling. Lastly, Device History Records (DHRs) were found to be inadequately established, with several DHRs missing required product labeling. During the closeout meeting, management, represented by General Manager Ms. Tammy M. Lemos, acknowledged these observations and committed to addressing all identified issues. The company promised to provide a written response to the FDA Form 483 within fifteen working days, indicating their intent to correct the deficiencies in line with relevant quality system regulations for medical device manufacturers.