FDA 483 - Exogenesis Corporation - April 12, 2022
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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.
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