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FDA Warns Epimed International for Supplier Control, Procedural Issues

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Lax process and quality control of supplied components helped land Irving, Texas-based Epimed International an FDA warning letter. Following a May 1 to 17 inspection of the company’s Johnstown, N.Y., plant, the FDA recounted flaws in the company’s supplier quality process, including a failure to establish and maintain procedures for accepting incoming products.
Devices & Diagnostics Letter