FDA issues warning for sterile drugmaker after 1,500 customer complaints

LSNE lyophilization vials
The FDA has ordered Indico Remedies to remedy its own issues that have led to 1,500 customer complaints about damaged drug vials.

The other regulatory shoe has dropped for India’s Indoco Remedies, which has had a sterile injectables plant blasted in an FDA warning letter for its laissez-faire approach to dealing with the hundreds of consumer complaints it receives each year.  

The warning letter for the plant in Goa, posted this week by the FDA, comes about six months after a preapproval inspection for a new injected drug resulted in the facility being slapped with a Form 483 with half a dozen observations.

Most troubling to inspectors was the fact that the drugmaker, over a four-year plus period, had received 1,500 complaints, a couple dozen a month, about cracked, broken, leaking and underfilled vials that never got their problems fixed. The damaged vials raise questions about the quality, integrity and sterility of the solutions it is making for clients, the agency said.

The FDA pointed out that even though Indico has tried a number of times over the years to deal with the filling line issues, it continued to receive “a large number of nonintegrity complaints” and that it was still unclear to the agency that Indoco’s latest plan was going to solve them. It noted Indico had been urged in an earlier inspection to do deal with the problems resulting in unhappy customers, although that was in an inspection five years earlier.

The FDA said that Indico’s threshold for initiating investigations was completely without merit. It noted that Indico’s own health hazard evaluation classified the defects as severe enough to that they might lead to “serious permanent injury” but that the company waved that off as requiring only a moderate response because it believed the chance of patients actually getting a defective med was low. 

“Any complaint of lost integrity of your sterile drugs should be considered as a serious problem with marketed product and trigger an appropriate investigation,” the letter read.

On top of all of that, the company wasn’t following its own agreement to notify customers if there were a lot of complaints so the drug seller could take steps to warn users of the potential for ineffective medications.

The agency had a long list of steps it wants Indico to take to deal with the problems and questions they raise for the quality of its products. For starters, it told the company to evaluate the risks from drugs still in the market in the U.S., do a new investigation into the root causes of the vial defects, take a look at its shipping conditions and evaluate all of its vendors. It suggested it might want to hire a consultant that can help it figure out how to get the plant in shape.