When AMRI bought Hyaluron in June 2010, it enjoyed a brief, two-month honeymoon before the FDA slapped the acquired sterile syringe and vial filling plant with a warning letter. The hangover has lasted three years, but now the agency has finally issued a letter to close out the failings it found at the Burlington site.
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.
India's Strides Arcolab some weeks back let the markets know it had received a Form 483 from U.S. regulators for one of its Indian plants, but it insisted it was on top of the problems. Whatever steps being taken were not enough, however, to keep the FDA from issuing a warning letter, which Strides announced Monday.
Altaire Pharmaceuticals recalled 9 lots of ophthalmic solution sold under Walmart, CVS and Target brands after receiving complaints of mold found in its 30 mL bottles after they were opened.
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.
Fresenius Kabi is taking seriously the FDA's allegations that staff at an Indian API plant lied to investigators and concealed data, and the generic drug unit of the German healthcare giant said it has fired the workers responsible.
Its announcement said the FDA had found problems in manufacturing quality, but its description did not come close to indicating the depth of the problems the FDA found there.
Bad news about Wockhardt's manufacturing quality keeps getting delivered to the Indian generic drugmaker. In a notification to stock exchanges Saturday, the drugmaker said it has now received a warning letter from the FDA, related to the agency's import alert announced two months ago.
The document takes the company to task for problems ranging from potential co-mingling of drugs to an incident in which it said the drugmaker failed to thoroughly investigate the impact of an injury to an employee.
In an earnings note today, BTG said its Biocompatibles unit had received an FDA warning letter sometime in the last three months for its plant in Oxford, CT. It said it had voluntarily halted production of brachytherapy products.