Emcure Pharmaceuticals has had its share of run-ins with the FDA in the past over the sterility of one of its Indian manufacturing plants. Now, it can notch one more black mark on its belt.
The FDA issued Emcure a warning letter earlier this month after investigators said the generic drugmaker did not properly investigate how microbial growth made its way into batches of injectable infection fighter amikacin sulfate and schizophrenia drug prochlorperazine edisylate.
After an inspection in February, investigators said the likely root cause of the failure was a lab error but that Emcure didn’t have the correct procedures in place to identify the problem.
“According to your sterility failure investigations, the most probable root cause for both events was laboratory error,” investigators wrote. “Your firm’s investigations substantially addressed the potential for microbial contamination during sterility testing, but deemphasized potential manufacturing causes.”
In late May, Heritage Pharmaceuticals, which distributes both Emcure drugs in the U.S., issued a voluntary recall of some sublots after microbial growth was found in unreleased supplies of the two products.
The East Brunswick, New Jersey-based distributor warned that patients injected with either of the drugs could get site-specific or even systemic infections that could lead to hospitalization and death.
The FDA provided a laundry list of improvements for Emcure, saying the voluntary recall didn’t go far enough to address deficiencies at the drugmaker’s Maharasthra, India, plant. Among the changes the FDA requested was a third-party review of Emcure’s inspection records and sterility test methods.
Most troubling for Emcure is that the most recent FDA warning letter was not the first time the agency has cited its plant for sterility problems.
In March 2016, the FDA issued another letter to Emcure citing microbial growth in sublots of two of their injectable products and a lack of sterile facilities. In one instance, the investigators said an “operator placed a cup on the floor … to collect water from a unit (and) used the cup contents to wet the mechanical assembly in the piston drive.”