Topic: FDA warning letter
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.
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 As Law360 reports, the agency has unpublished a warning letter to the company, issued last September, that took issue with the company's marketing practices.