An Aurobindo plant that received a scathing FDA rebuke several years back is shutting its doors for good.
Indian generics giant Aurobindo is closing shop at its Aurolife Pharma unit in Dayton, New Jersey, where 99 jobs will get the chop on April 26. The closure, first reported by Stat News, was detailed in a state Worker Adjustment and Retraining Notification notice.
The company did not immediately respond to Fierce Pharma’s request for comment on the matter. Aurobindo did not say why it was closing the facility, nor did it comment on potential solutions for employees facing termination.
The Garden State facility was in the FDA’s crosshairs as recently as October 2020, when the regulator issued a warning letter for a raft of issues at the New Jersey plant including water leaks and impurity concerns tied to drug ingredients for a generic antipsychotic medicine.
During an inspection between January and February of 2020, the FDA found multiple water leaks in Aurolife’s packaging and encapsulation rooms, presaging potential contamination for a range of the company’s drugs, the agency said.
The FDA pointed out four instances in 2018 during which ceiling leaks in Aurolife’s encapsulation room contaminated multiple batches of the generic anticonvulsant gabapentin, plus at least five other leaks in the company’s packaging room. Some of those leaks were happening directly over Aurolife’s packaging lines, which threatened the integrity of “moisture sensitive” drugs like diabetes med pioglitazone hydrochloride, which Aurolife had been producing on site, the FDA said at the time.
Elsewhere, Aurobindo has run into recent trouble with the FDA at its plant in Hyderabad, India, where the company was hit a warning letter following an August 2021 inspection.
In its January 2022 letter, the agency chided Aurobindo for failing to adequately investigate batch failures of active pharmaceutical ingredients as well as failing to evaluate the possible effect of changes on intermediates and APIs manufactured at the site.
The FDA flagged similar violations it brought to the company during a meeting with Aurobindo representatives in July 2019, adding that “repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.
Back in Dayton, New Jersey, the FDA in 2020 recommended Aurobindo hire outside help to rectify the situation at its Aurolife facility. Aurobindo is currently in the process of selling off its injectables business, Stat points out.