Day

May 22, 2014
STERIS Corporation Product:facility sterilizes medical devices Date:5/22/2014 1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100. Your CAPA procedure, PROC-00007, Revision 19, is deficient in that it does not adequately describe how to identify, correct and prevent the recurrence of nonconforming product and other...
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It appears that the Center directed ORA to inspect Class I firms and provided each regional/district offices with a list of 50 firms to choose from. These inspectionsappear to be in part a validation exercise of the risk based approach to only inspecting higher risk firms. We are assuming it is for the remainder of...
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Company: Baxter Corporation EnglewoodDate of Enforcement Report:4/2/2014 Class I: PRODUCT Baxter Corporation Englewood, ABACUS Total Parenteral Nutrition Calculation Software, Versions 3.1, 3.0, 2.1, and 2.0 – Software Errors May Cause Toxic or Overdose Symptoms. ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition),...
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