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Clear Blue Blog

Top 5 Measurable Costs of a Warning Letter

November 21, 2013 by Drexel Rothrauff


In part one of this two part blog series, we laid out the top 5 immeasurable costs to an FDA warning letter; including reputation damage and competitor leverage (read part 1 here). In this part, we will discuss the most common and top costs to receiving a warning letter from the FDA.  We have witnessed these top 5 cost areas over and over again in Life Science companies who have received a warning letter/483.

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3 Ways to Increase Profitability and Compliance

October 1, 2013 by Drexel Rothrauff


The Pharmaceutical, Biotech, and Medical Device industries are continuously hounded by tightening regulations, warning letters and fines.  With heightened FDA enforcement, most Life Sciences companies focus on meeting FDA regulations rather than improving the overall quality of their product. By focusing on improving quality from product inception, Life Sciences companies will naturally increase their compliance and profitability.

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Top Maintenance Trends in FDA Inspections

September 6, 2013 by Jim Erickson


The FDA is displaying heightened interest in maintenance and asset management during inspections.  Along with the future adoption of ISO 55000 scheduled for February 2014, there is a strong focus on asset management and a drive toward risk based maintenance standards in the pharmaceutical and biotech industries.

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Increased GMP Compliance Enforcement

January 8, 2012 by Jim Erickson


The recent Bio/Pharmaceutical Outsourcing Report article, FDA Increases Vigilance on Aseptic Processing Facilities does a good job describing the latest changes in the way the FDA is inspecting facilities.

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