FDA WARNING_LETTER - Global Medical Technology SL - October 10, 2019

On December 20, 2019, the FDA issued a Warning Letter to Mr. Génova following an inspection of his firm in San Sebastian De Los Reyes Madrid, Spain, from October 7-10, 2019. The inspection revealed that the firm's Platinum GMT IPL System Cloud is an adulterated device under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information under 21 U.S.C. § 360i and 21 CFR Part 803.

Key violations include: 1. Failure to establish and maintain procedures for nonconforming product control (21 CFR 820.90(a)). 2. Failure to establish and maintain adequate design control procedures (21 CFR 820.30(a)), including lack of design history file records, system/software validation, design plan, inputs, and reviews. 3. Failure to establish and maintain corrective and preventive action procedures (21 CFR 820.100(a)). 4. Failure to establish and maintain adequate equipment calibration procedures (21 CFR 82