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FDA Regulatory Compliance for the Pharmaceutical, Biotechnology and Medical Device Arenas

Steris Corporation Warning Letter February 9, 2011

February 22, 2011 By Barry Friedman 1 Comment

 Warning Letter  February 9, 2011 Steris Corporation “Chemical Indicators (Verify SixCess Class 6 Challenge Packs and Chemical Indicators) Should Not Replace Biological Indicators (BIs)” Comment Steris Corporation has developed chemical indicators that have been approved by the FDA to “monitor physical conditions”.  While the FDA has approved this use, they recently issued … [Read more...]

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