India's Aurolife under water with the FDA after chronic ceiling leaks imperil generics produced on site

In the antiseptic world of drug manufacturing, cleanliness is key and outside contamination is a drugmaker's worst enemy. That's why, generally speaking, chronic water leaks from the ceiling are a bad thing—a fact an Indian generics maker is having to learn the hard way. 

Aurolife, a subsidiary of Aurobindo Pharma, failed to adequately address a raft of issues at its Dayton, New Jersey, plant, including a flood of water leaks and impurity concerns over active pharmaceutical ingredients (APIs) used in one of its generic antipsychotics, the FDA said in a warning letter posted online Tuesday.

During an inspection between January and February, the FDA found numerous water leaks in the drugmaker's packaging and encapsulation rooms, a potential sign of contamination for a range of its generic medicines. 

The FDA noted four instances in 2018 in which the ceiling in Aurolife's encapsulation room leaked, contaminating multiple batches of generic anticonvulsant gabapentin. There were at least five other leaks in Aurolife's packaging room, the FDA noted, including while workers were loading tablets into their packages.

Some of the leaks occurred directly over the packaging lines, posing a contamination risk to "moisture sensitive" drugs including diabetes medicine pioglitazone hydrochloride, which Aurolife produces on site. 

In its response, Aurolife pledged to recall unnamed drugs cited in the FDA's Form 483, but the agency found Aurolife's "executive management failed to fully recognize the risks from these leaks" and didn't outline an adequate plan to conduct repairs. 

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FDA investigators also found that Aurolife released five batches of API used to make its generic olanzapine tablets despite registering unacceptably high levels of an unknown impurity. A sixth batch of API was rejected after Aurolife found another unknown impurity above acceptable limits. 

The firm also failed to ensure its API was kept at a constant refrigerated temperature during storage, the FDA wrote. 

During batch testing of the finished olanzapine tablets, Aurolife found high levels of an unknown impurity but later passed the tablets after further testing. The drugmaker blamed the impurity test failure on contamination from a mortar and pestle "without supporting evidence," the FDA wrote. 

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In its March response to an FDA Form 483, Aurolife disputed the FDA's findings that its API registered unacceptably high impurity levels—a fact the FDA noted in its letter. In all, the FDA found Aurolife hadn't done enough to ensure its follow-up testing helped prevent impurities in its drugs. 

The FDA also found that Aurolife failed to maintain adequate procedures for cleaning, leading to a "powder residue" left over after a "major" cleaning in the company's granulation room. 

Editor's Note: This story has been updated to correct an error. Aurolife's plant is located in Dayton, New Jersey. The company's headquarters are in Hyderabad, India.