# FDA WARNING_LETTER - Lymol Medical Corporation - February 12, 2020

Source: https://www.globalkeysolutions.net/records/warning_letter/lymol-medical-corporation/f834f355-cc16-45e4-b5ee-3a4b1b3d1f5d

> FDA WARNING_LETTER for Lymol Medical Corporation on February 12, 2020. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Lymol Medical Corporation
- Inspection Date: 2020-02-12
- Product Type: Devices
- Office Name: Office of Medical Device and Radiological Health Operations (Division 1)
- Summary: 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.
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## Related Documents

- [483 - 2020-02-12](https://www.globalkeysolutions.net/records/483/lymol-medical-corporation/b35c4532-4f83-4d8e-bc38-8a85fbea2489)
- [483 - 2021-07-29](https://www.globalkeysolutions.net/records/483/lymol-medical-corporation/6442399f-6444-475e-b2ec-fb98d1070da3)

## Related Officers

- [Program Division Director](https://www.globalkeysolutions.net/people/joseph-s-matrisciano/62ff5cd6-c3ab-4443-bf26-f61a512f3960)

Company: https://www.globalkeysolutions.net/companies/lymol-medical-corporation/a98bac62-27b5-4afb-897b-aed3e10e1d9c

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-operations-division-1/c2b03748-4c7c-4f76-b2ea-bc8f47e6e7f2