FDA EIR - Ecotec Manufacturing, Inc. - June 26, 2019

An FDA inspection of Ecotec Manufacturing, Inc., a medical device manufacturer, was conducted from June 24-26, 2019. The inspection revealed significant violations of regulatory requirements. Ecotec was found manufacturing and distributing "Medical Freeze Spray" products for cryotherapy wart/skin tag removal, a Class 2 medical device use requiring 510(k) clearance, which the firm had not obtained. Numerous deficiencies were also identified across Ecotec's quality management system, governed by 21 CFR Part 820 (Quality System Regulation) and 21 CFR Part 803 (Medical Device Reporting). Key issues included a lack of written procedures for design controls, design history files (including verification and validation for temperature and intended use), purchasing controls for critical suppliers, corrective and preventive actions, internal quality audits, and incoming acceptance for gases. Inadequate process validation for automated crimping/filling equipment and inconsistent finished device acceptance procedures were also noted. Furthermore, complaint handling procedures were insufficient, failing to detail investigation activities or timely processing, and the firm lacked written Medical Device Reporting (MDR) procedures. Ecotec's President promised to address all observations. The FDA warned that failure to implement adequate corrective actions could lead to enforcement, including a Warning Letter or product seizure.