# FDA 483 - ConMed Corporation - September 22, 2020

Source: https://www.keypedia.com/records/483/conmed-corporation/13ce3e78-bdc7-45cd-8e6b-82570befa5a9

> FDA 483 for ConMed Corporation on September 22, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: ConMed Corporation
- Inspection Date: 2020-09-22
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: ConMed Corporation, a medical device manufacturer in Utica, NY, received a Form FDA 483 for significant quality system deficiencies. The firm failed to adequately investigate numerous complaints related to its AirSeal IFS device, including critical malfunctions. Additionally, ConMed did not submit required Medical Device Reports (MDRs) within the mandated 30-day timeframe for device malfunctions that could lead to serious injury.

## Related Documents

- [483 - 2020-09-22](https://www.keypedia.com/records/483/conmed-corporation/f8aaf5c2-85ac-4fd6-8854-82184123eeb3)

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)
- [investigator](https://www.keypedia.com/people/wendy-m-stone/715b04f5-3949-4ca6-9bda-26ff611e9354)

Company: https://www.keypedia.com/companies/conmed-corporation/ab83684d-062e-47ad-9694-df520179a67e

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961