# FDA 483 - Jarvis Surgical, Inc. - July 07, 2022

Source: https://www.keypedia.com/records/483/jarvis-surgical-inc/e46acb96-5d26-4efb-a826-ef169ec17392

> FDA 483 for Jarvis Surgical, Inc. on July 07, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jarvis Surgical, Inc.
- Inspection Date: 2022-07-07
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Jarvis Surgical, Inc., a medical device contract manufacturer in Westfield, MA, was cited for failing to establish procedures to prevent contamination. The firm routinely used a commonly known allergen, which is a restricted substance per quality agreements and customer requirements, in the manufacturing processes for hip, shoulder, knee, and spine implants. This indicates a significant lapse in contamination control and quality system adherence.

## Related Officers

- [Power Trader/Data Scientist](https://www.keypedia.com/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

Company: https://www.keypedia.com/companies/jarvis-surgical-inc/a5cb5e80-515a-4de2-86bc-492d70a9b521

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