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3.1 DermaRite Industries, LLC (New Jersey/NY Area Context): The Testing Into Compliance Paradigm The warning letter issued to DermaRite Industries, LLC (Warning Letter 320-26-09, October 27, 2025) provides a definitive case study of how "testing into compliance" manifests within the US regulatory jurisdiction.(2) The Violation: The firm obtained an initial OOS result for Total Aerobic Microbial Count (TAMC) on a batch of DermaKleen (Lot 40375A)
