Exogenesis Corporation – FDA 483, Apr 12, 2022

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.