Topic: FDA warning letter
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.
India’s Polydrug Laboratories got an FDA warning letter for ignoring customer complaints that they discovered hair, an insect, a scoop and goggles in various API deliveries.
On second thought, Pacira Pharmaceuticals, the FDA might just take it back. As Law360 reports, the agency has unpublished a warning letter to the company, issued last September, that took issue with the company's marketing practices.