Ranbaxy's Reign of Error Continues as FDA Flunks Its New York Drug Factory
A Ranbaxy factory in New York failed an FDA inspection because it made diabetes and antacid medicines with "black particles" and "cardboard" floating in it, and ignored anomalous testing results in its laudanum product, which it was selling without FDA approval.
It's the latest in a series of screwups at the disaster-prone company. The FDA previously accused Ranbaxy of faking test data, two of its Indian factories are banned from exporting products to the U.S. for manufacturing failures, and it twice recalled lots of acne medication last year.
Ranbaxy said it received a warning letter about violations in late December. But the FDA didn't release the letter until this month, and that flew under the radar because it was addressed to Ohm Labs, Ranbaxy's Gloversville, N.Y., facility.
Behind the bafflingly technical language that the FDA favors for its warning letters you can sense that the agency is frustrated and impatient. The writer -- New York acting district director Laurence Daurio -- all but accuses Ranbaxy of trying to gloss over its problems rather than fix them.
He describes "black particles [found] in a single bottle of Metformin HCI Oral Solution, ... the source of the particles may have originated from worn nozzle seals on the filling machines." Daurio then says Ranbaxy responded by misstating the FDA's complaint and suggesting a hypothesis for the the black particles that was inconsistent with the FDA's complaint about them. "In addition, we have determined your investigation to be inadequate," Daurio wrote.
Rather than look for the source of the particles, Ranbaxy had apparently suggesting "tracking and trending" the metformin to see if it happened again. Daurio responded:
Tracking and trending of a complaint is only part of a sufficient investigation and does not substitute for an investigation or provide adequate justification to circumvent the investigation requirement.Worse, bits of garbage ended up in its generic version of the antacid Zantac, ranitidine:
Your May 20 and July 7, 2008 investigations into fiber and cardboard particles found in three batches of Ranitidine HCI Solution were inadequate. ... You released the batches of drug product based on questionable visual inspections of amber color bottles filled with product.Ranbaxy didn't bother to look at whether plastic wrap from the bottles was at fault, the FDA said.
The company also simply ignored an out-of-specification test for its opium tincture product. (Opium tincture is better known as laudanum, the highly addictive painkiller used by Mary Todd Lincoln, President Lincoln's wife.) Ranbaxy's excuse? The results were taken from a four-year span and in that time there had been staffing turnover, so obviously there might be fluctuations in test results.
Daurio saved the killer blow for the end of his letter:
... your firm is manufacturing and distributing the prescription drug Opium Tincture USP (Deodorized - 10 mg/mL). Based on our information, there are no FDA-approved applications on file for this drug product.Selling a drug without FDA approval is just about the dumbest thing a drug company can possibly do. (Bayer was cited for doing the same thing with an aspirin product last year.) And yet, despite more than a year of FDA scrutiny, Ranbaxy managed to do it.
Hat tip to FiercePharma.