The steady string of warning letters issued to Indian drug and ingredient makers as the FDA has added to its staff in India is fueling the perception that the country has issues when it comes to quality. Now another warning letter has been issued.
Last year, FDA inspectors said employees at the Canton Laboratories active pharmaceutical ingredient facility in Vadodara, India, were not getting equipment clean enough between batches to prevent cross contamination. The company's certificates of analysis had been showing that its APIs were within limits for microbial and metal content, but there was a problem with those tests: They never occurred.
Amgen has been issued an FDA warning letter for problems the agency says it found at its plant in Thousands Oaks, CA, which makes prefilled syringes and related devices used for its osteoporosis drug Prolia, and for Enbrel, the autoimmune disease treatment it shares with Pfizer.
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.
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.
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.
Fresenius Kabi, the generic drug unit for the German healthcare company, has received its second FDA warning letter n 18 months, this time for a plant in India. And it has had two recent recalls because of glass particles found in vials of injectable drugs.
Just months after signing a consent decree for the manufacturing mess in its Ben Venue subsidiary, Boehringer Ingelheim finds itself on the firing line with the FDA again, this time for particle contamination in an API produced 4 and 5 years ago.
In 2011 when serious manufacturing issues surfaced at the Ben Venue plant in Ohio, Pfizer ($PFE) decided to dump it as a supplier for its diluting agent for the cancer drug Torisel. In fact, Pfizer said it had an exit strategy for all of the drugs being made by the Boehringer Ingelheim unit.
Late last month, Alexion Pharmaceuticals ($ALXN) assured investors it was on top of the issues with its pricey rare-disease drug Soliris. But the FDA report indicates that Alexion has had trouble figuring out the source of the contamination and so adequately attacking it.