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May 14, 2013

Dear Subscriber,

Here's your current issue of Pharma Quality Advisor. To view an article, click on a headline.

CMI Gets FDA Warning Letter For Not Testing Raw Materials
The FDA has warned CMI, an Ontario, Canada-based maker of digestive enzyme therapy drugs, for failing to test raw materials before using them in finished products.

FDA Inspection Flap Prompts Alexion Risk Assessment Reform
Alexion is reviewing its analytical methodologies and procedures to ensure its risk assessments meet the FDA’s expectations, the drugmaker said. Those assurances follow the agency’s rare posting of the drugmaker’s response to a 2012 inspection.

Compounders Counter FDA Call for More Inspection Authority
CDER Director Janet Woodcock, appearing before a Senate panel on May 9, reiterated the FDA’s call for enhanced authority to seize compounding pharmacy records. But a leading association of compounders said such powers should remain with the states.

Canada Extends GMPs to All APIs
The same good manufacturing practices (GMP) that finished-dose pharmaceutical companies in Canada are required to follow will soon apply to all active pharmaceutical ingredients (API) used in the country. The supply-chain-tightening move sets forth new mandates on licensing, recordkeeping and API tracking.

Warning Letter - CMI Cosmetic Manufacturers, Inc. - April 25, 2013


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