Monthly Archives: February 2011

SANOFI AVENTIS DEUTSCHLAND GmbH WARNING LETTER

WARNING LETTER  FEBRUARY 9, 2011 SANOFI AVENTIS DEUTSCHLAND GmbH 1. Your firm has not established or followed appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile [21 C.F.R. § 211.113(b)].  Comment  21 C.F.R. § 211.113(b) states that … Continue reading

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USP BACTERIAL ENDOTOXIN TEST

The USP has announced that USP<85> will become effective in April 2011.

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Steris Corporation Warning Letter February 9, 2011

 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 … Continue reading

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NEW Webinars/Seminars — Barry A. Friedman, PhD

Please follow all upcoming webinars/seminars at http://www.friedmanconsulting.com

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Baxter Healthcare Puerto Rico Warning Letter 1/20/11

Warning Letter January 20, 2011 Baxter Healthcare Puerto Rico 1. The Jayuya Facility (Puerto Rico) A. CGMP Violations 2. Your firm failed to ensure your container closure system provided adequate protection against foreseeable external factors in storage and use that … Continue reading

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Baxter Healthcare Puerto Rico Jayuya Warning Letter 1/20/2011

Warning Letter January 20, 2011 Baxter Healthcare Puerto Rico 1. The Jayuya Facility (Puerto Rico) A. CGMP Violations 1. Your firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether … Continue reading

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Baxter Healthcare Corp Puerto Rico Warning Letter – Just Issued

The FDA just announced the Warning Letter for Puerto Rico -  Comments to follow Baxter Healthcare Corporation 1/20/11     Department of Health and Human Services Public Health Service Food and Drug Administration   San Juan District 466 Fernandez Juncos … Continue reading

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