# FDA 483 - Lymol Medical Corporation - July 29, 2021

Source: https://www.keypedia.com/records/483/lymol-medical-corporation/6442399f-6444-475e-b2ec-fb98d1070da3

> FDA 483 for Lymol Medical Corporation on July 29, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lymol Medical Corporation
- Inspection Date: 2021-07-29
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Lymol Medical Corporation in Woburn, MA, a medical device manufacturer, received a Form FDA 483 with four repeat observations during an inspection from July 19-29, 2021. The inspection revealed significant issues with process validation, design control procedures, device history record maintenance, and supplier quality agreements. These findings indicate a lack of adequate quality system controls for medical device manufacturing.

## Related Documents

- [483 - 2020-02-12](https://www.keypedia.com/records/483/lymol-medical-corporation/b35c4532-4f83-4d8e-bc38-8a85fbea2489)
- [WARNING_LETTER - 2020-02-12](https://www.keypedia.com/records/warning_letter/lymol-medical-corporation/f834f355-cc16-45e4-b5ee-3a4b1b3d1f5d)

## Related Officers

- [Sunita Pandey](https://www.keypedia.com/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)
- [Nabil Nakhoul](https://www.keypedia.com/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

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