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Theqmnweeklybulletin

April 11, 2014

Vol. 6 No. 15

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West-Ward Closes Out Warning Letter After Quality Revamp

The FDA has closed out a warning letter issued to West-Ward Pharmaceuticals after the generic drugmaker completed a two-year overhaul of parts of its quality system. Read More

FDA Adds Apotex to India-Based Import Ban List

The FDA has banned Canadian generics maker Apotex from importing drugs to the U.S. made at its Bangalore, India, site, pending quality upgrades. Read More

LNK Rapped for Unsanitary Processing Conditions

Dirty equipment and a leaky water system led to a Form 483 for drugmaker LNK International. Read More

23andMe Pulls Tests From Market as Part of Warning Letter Closeout

The FDA has closed out a warning letter issued to online genetics testing firm 23andMe, following the company’s agreement to take its health-related tests off the market. Read More

EU Launches Surprise Quality Audits Worldwide

Beginning this month, all devicemakers holding CE certificates for devices classified as Class IIa and above should be prepared for unannounced quality system visits by notified body inspectors. Read More

B. Braun Gets 483 for Poor Inquiries into Batch Problems

The FDA found B. Braun’s investigations into leaky products to be lacking in detail, handing the drugmaker a Form 483. Read More

Experts Urge Stronger Chinese Supply Chain Surveillance to Protect U.S. Consumer

Although great strides have been made by Chinese officials to improve the quality of drugs made in the country, more needs to be done, according to U.S. regulators and drug safety advocates. Read More

C.R. Bard Form 483 Discusses Storage Area Control, DHR

C.R. Bard received an FDA Form 483 for storage area control and other manufacturing issues. The company had not performed temperature mapping studies to find “cold spots, hot spots, dead spots.” Read More