Topic: FDA 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.
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.
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.
The FDA has issued warning letters to plants operated by Shanghai Desano Chemical Pharmaceutical and Chongqing Lummy Pharmaceutical, slamming them both for manipulating testing and turning in falsified batch test results on APIs.
When FDA inspectors found issues during a recent inspection at KO DA Pharmaceutical, the Taiwanese API maker decided to quit shipping products to the U.S. rather than change its production.
Faking data has won another Indian drugmaker a stern warning from the FDA, this time for a Megafine Pharma plant whose products the FDA banned last year.
CordenPharma last year got FDA approval to produce sterile products at a plant in Italy. Now, it has gotten an FDA warning letter for the same plant.
The FDA has slammed a Shanghai API maker in a warning letter for what it called “systemic data manipulation” which raised questions about the quality of the Chinese company’s products.
The FDA has sent a warning letter to an API producer in Germany that the agency says has a host of production problems.
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.