FDA Warns Epimed International for Supplier Control, Procedural Issues
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
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The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important. But creating an FDA-proof CAPA isn’t easy. If only you could pick the brain of someone who is coping successfully with CAPA — the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA. Well, you can. Register today.Read More
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