# FDA 483 - Exogenesis Corporation - April 12, 2022

Source: https://www.keypedia.com/records/483/exogenesis-corporation/2dfdc332-77b2-4d99-84a8-24f5fa6a3349

> FDA 483 for Exogenesis Corporation on April 12, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Exogenesis Corporation
- Inspection Date: 2022-04-12
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Exogenesis Corporation in Billerica, MA, a manufacturer of synthetic surgical mesh, received two observations during an FDA inspection. The firm was cited for failing to adequately establish procedures for environmental control, specifically regarding viable and non-viable particulate monitoring in its Class 7 manufacturing room. Additionally, the company lacked documented statistical rationale for sampling plans used in product testing, such as the Exogenesis nanoMesh pouch peel test.

## Related Officers

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

Company: https://www.keypedia.com/companies/exogenesis-corporation/0797c126-f7f8-4adf-bad2-fbfbda22a3c6

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