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Warning Letter

Latest Headlines

Latest Headlines

CorePharma gets closeout letter for NJ plant

The only good part of receiving an FDA warning letter is when a company gets a closeout letter that says it has finally met FDA expectations. It has taken three years, but generics maker CorePharma says it has gotten its closeout for a plant in New Jersey.

FDA on Apotex's case for plant problems

The generic drug manufacturer, which for nearly two years had its products banned from the U.S., has received a warning letter for two of its in Canada plants, one in Ontario and one in Toronto that has received a warning letter before.

Plant problems stymie Impax NDA, FDA says

Plant problems don't always mean an interruption of production of existing product. Sometimes they can keep a new drug from potentially getting to market, Impax Pharmaceuticals has found.

FDA inspectors come down hard on Taiwan plant

FDA inspectors have come down hard on a drugmaker in Taiwan, issuing a warning letter to Taiwan Three Mast Pharmaceutical in Tainan City for serious manufacturing violations.

Bracco Diagnostics recalls angiography drug over particulates

Another injectable drug is being recalled after particles were seen in the finished product.

FDA to Congress: Agency can't dodge plant problems to avoid shortages

Issuing its defense of the part it has played in drug shortages, the FDA says it is very concerned about the problem but essentially tells Congress that it can't turn its head when drugmakers turn out substandard and contaminated products that are going to hurt patients.

Drugs mislabeled after Shamrock ignored FDA

Not following through to fix problems noted by FDA inspectors is sure to land manfuacturers in trouble with the FDA, and contract manufacturer Shamrock Medical Solutions has received a warning letter that proves it.

FDA says NuSil must get at root of contamination

Insufficient equipment cleaning led a California API maker to recall several lots of Simethicone Emulsion USP (30%) that had microbial contamination.

Nobilus Poland plant gets import ban after FDA warning

The FDA issued warning letters to an API plant in Poland, a drug manufacturing plant in Mexico and a medical device manufacturer in China.

FDA cites Gulf Pharmaceutical for predating documentation

The FDA has raised serious concerns about the manufacturing and data security processes at a plant in the United Arab Emirates operated by Gulf Pharmaceutical Industries.