FDA WARNING_LETTER - Lymol Medical Corporation - February 12, 2020

The FDA issued a Warning Letter to Lymol Medical Corporation following an inspection from February 3-12, 2020, which identified significant violations of the Quality System regulation (21 CFR Part 820) for their Elite X Class Rigid Bronchoscope System and Premier S Class Silicone Stents. These devices were deemed adulterated.

Key violations include: 1. **Lack of Process Validation (21 CFR 820.75(a)):** Failure to validate manual cleaning, sterilization, and storage conditions for the Bronchoscope System and Optical Telescopes. 2. **Inadequate Design Change Control (21 CFR 820.30(i)):** A design change to the Jet Venturi Injector was implemented without proper validation or verification, and performance testing under actual or simulated use conditions was not conducted. 3. **Deficient Acceptance Activities (21 CFR 820.80(a)):** Failure to ensure specified requirements for products were met, with instances of Universal Barrels failing inspection but lacking documented acceptance/rejection status. 4. **Failure to Evaluate Complaints for MDR Reporting (21 CFR 820.198(a)(3)):** Complaints involving device breakage (Tracheal tube, barrel) were not evaluated to determine if Medical Device Reports (MDRs) were required, and MDR decision trees were not completed. 5