FDA EIR - ICU Medical de Mexico, S.A. de C.V. - February 18, 2016

An FDA inspection of ICU Medical de Mexico, S.A. de C.V., a manufacturer of Class II Intravascular Infusion and Cardiac Tubing Sets, was conducted from February 15-18, 2016. This QSIT Level II inspection, carried out under C.P. 7382.845, focused on corrective and preventive actions, production and process controls, and management controls, aligning with the Quality System Regulation (21 CFR Part 820).

The inspection identified three significant deficiencies, detailed in an FDA Form 483. Firstly, a critical manufacturing process, specifically UV bonding, was not adequately validated, lacking documented operator certifications and personnel training verification within validation procedures (21 CFR 820.75(a)). Secondly, the company's internal quality audit procedures were not fully implemented, with 2014 and 2015 audits failing to cover all required sections of the Quality System Regulation (21 CFR 820.22). Lastly, acceptance activities demonstrated inadequate documentation, as the results of essential flow and occlusion functional tests were not recorded in Device History Records (21 CFR 820.80(e)).

Management, led by Mr. Krishna Uppugonduri, Vice President, Quality & Regulatory Affairs, acknowledged these observations and committed to corrective actions. A detailed written correction plan is to be submitted to CDRH within 15 business days. The FDA cautioned that failure to promptly address these serious conditions could lead to regulatory sanctions, including the detention of products destined for the U.S.