Warning Letter

Latest Headlines

Latest Headlines

Another Fresenius plant gets warning letter

German drugmaker Fresenius received a scathing warning letter in July for a drug plant in India. Now, a blood-products plant in Puerto Rico has been sent a warning for a labeling issue which the agency said should have been resolved months, even years ago.

FDA warns Agila plant over torn gloves

In a warning letter, the FDA has chastised the management of an Agila Specialties plant in India that Mylan ($MYL) is buying from Strides Arcolab for using defective gloves in the aseptic processing area and then not taking the problems seriously enough.

FDA notes data falsification at Indian plant

An FDA warning letter to Indian drugmaker Posh Chemicals says that a quality-control chemist admitted during a March inspection that he "had recorded false visual examination data in the logbooks for reserve samples" at the order of a manager.

CEO says Hospira is making progress on manufacturing fixes

Hospira rebounded from losses and reported a second-quarter profit, yet the drug and device maker has revealed that its work to improve quality-control issues at plants across the world is far from over.

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.