# FDA 483 - Lymol Medical Corporation - February 12, 2020

Source: https://www.keypedia.com/records/483/lymol-medical-corporation/b35c4532-4f83-4d8e-bc38-8a85fbea2489

> FDA 483 for Lymol Medical Corporation on February 12, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lymol Medical Corporation
- Inspection Date: 2020-02-12
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Lymol Medical Corporation in Woburn, MA, revealed significant deficiencies in its quality system for the Elite X Class Rigid Bronchoscope System. The firm failed to validate critical processes, adequately establish acceptance and design change procedures, and maintain essential device records. These issues indicate a broad breakdown in quality management practices, including repeat observations from previous inspections.

## Related Documents

- [WARNING_LETTER - 2020-02-12](https://www.keypedia.com/records/warning_letter/lymol-medical-corporation/f834f355-cc16-45e4-b5ee-3a4b1b3d1f5d)
- [483 - 2021-07-29](https://www.keypedia.com/records/483/lymol-medical-corporation/6442399f-6444-475e-b2ec-fb98d1070da3)

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

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

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94