FDA WARNING_LETTER - LeMaitre Vascular, Inc. - April 16, 2025

**FDA Warning Letter Summary**

**Company Name:** LeMaitre Vascular, Inc.

**Inspection Dates:** March 4, 2025 - April 16, 2025

**Main Violations/Issues:** 1. **Quality System Regulation Violations:** The FDA inspection identified that Artegraft Collagen Vascular Grafts are adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act. The manufacturing processes did not comply with current good manufacturing practices as outlined in 21 CFR Part 820. Key issues included: - Inadequate procedures to prevent contamination of equipment or products, with inconsistencies in water sampling procedures and inadequate documentation of system sanitization. - Changes in sterilant solutions without proper documentation or assessment of impact on product biocompatibility.

2. **Environmental Control Issues:** The firm failed to establish and maintain procedures to control environmental conditions that could adversely affect product quality, as required by 21 CFR 820.70(c). Specific shortcomings included: - Environmental monitoring procedures that do not reflect actual production conditions, such as inappropriate cleaning methods before sample collection and inadequate specifications for air sampling.

**Regulatory Framework:** The violations fall under the Federal Food, Drug, and Cosmetic Act and the Quality System regulation (21 CFR Part 820).

**Required Actions:** The FDA requires LeMaitre Vascular, Inc. to: - Provide a comprehensive assessment of the impact of the new sterilant on product biocompatibility and potential contaminants. - Submit revised documentation and procedures that address the noted deficiencies. - Ensure future compliance with the Quality System regulation and environmental control requirements.

The FDA"s evaluation of the firm"s initial response concluded it was inadequate, and additional information and corrective actions are necessary.