Topic: FDA warning letter

FDA sign

FDA cites drug repackager in warning letter

A drug repackager that specializes in single-dose repackaging has found itself in trouble with the FDA, which issued it a warning letter for both manufacturing issues and for marketing what the FDA said were unapproved and misbranded drugs.  
GlaxoSmithKline HQ

FDA savages GSK plant in warning letter

The handwriting was on the wall for a GlaxoSmithKline API operation in the U.K. when the drugmaker recalled more than 425,000 Bactroban antibiotic products last fall after an inspection by the FDA. Now the extent of the problems at the facility have been laid out in an agency warning letter.

Chinese API maker spanked in warning letter

Some FDA warning letters are long, drawn-out documents listing specific and multiple violations and sometimes offering a blueprint for fixing issues. Others are short and to the point, essentially saying a drugmaker doesn’t have its manufacturing act together and until it does, the FDA is not going to approve its products for sale in the U.S. China’s Guangzhou Haishi Biological Technology got one of the short ones.

API repackager in hot water with FDA

A U.S. API repackager is in hot water with the FDA, earning itself a warning letter by taking liberties with the expiration dates on the drugs it repackages and having a quality unit that pretty much shirked its responsibilities.