The FDA sent a warning letter to Canton Laboratories in Vadodara, India, in February for a list of serious infractions, including falsifying data. The agency has taken the next step, issuing an import alert that bans products from the facility.
According to a warning letter sent Feb. 28 and posted this week on the FDA website, Total Pharmacy Services has been making domperidone, a drug some breastfeeding women take to boost lactation.
The European Medicines Agency is now making public its reports on companies that have failed plant inspections. The FDA has made warning letters and some Form 483 reports public for some years, but the EMA had not, according to Pharmafile, which went through the nearly 7 dozen reports in the data base that date back to 2007.
Baxter International, which has faced FDA criticism for operations at some of its plants, is recalling 5 lots of products after particulate was found in two different solutions.
India's Wockhardt, whose issues with the FDA and regulators in Europe just keep piling up, has been hit with two more import alerts. This time, the bans are for the veterinary drugs made at the same two plants the FDA banned from shipping human drugs.
The FDA has come down on a New Jersey over-the-counter maker of lotions, creams and other dermatology products, including sanitizing gel, for not testing the water used in its OTC products to see if it was sterile.
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.