The FDA has slammed generic drug maker Hetero Labs with a Form 483 after an inspection of one of its warehouses in India uncovered flying birds, skittering lizards and roaming cats, among a host of other infractions.
The inspection, conducted at the drugmaker’s warehouse in the Indian port city of Visakhapatnam from Sept. 19-26, yielded six observations in total.
The manufacturing write-up kicked off with an account of the FDA team being denied entry for two hours to the facility, which it asserts had not been previously disclosed to the agency as a site used for active pharmaceutical ingredient storage.
While being detained by company security, inspectors noted the assistant manager and warehouse staff “had ran out of plain sight upon announcing our intent to inspect the facility,” the FDA said in its letter.
After eventually gaining access to the warehouse, the inspectors observed damaged drums of API with torn labels, and some with open lids, which the FDA said indicated there was no procedure for inspecting and maintaining the integrity of the containers during receipt or storage.
In its defense, the Hetero team argued that the warehouse was used to store materials for another in-house manufacturing facility that only distributes to the Indian market. The company's assistant warehouse manager and assistant vice president of the warehouse pleaded ignorance as to "how, why and when" drums destined for FDA-registered production plants had wound up at the site.
The FDA inspectors also noted multiple pest and animal sightings during their visit.
“This included birds flying throughout the warehouse buildings, bird droppings on top of [redacted] drums, birds’ nest observed within the top seams of the warehouse, crawling lizards, and cats crawling in between pallets and rows of API and intermediate drums,” the inspectors said.
There was, they concluded, “no procedure or system for pest control."
Hetero was also scolded for not having established quality control oversight or procedures for storing API, intermediates and raw materials.
And, apart from issues at the gates, the FDA team was further refused access to a truck full of drums parked at the warehouse loading dock. The vehicle later left the site without explanation or inspection. Another truck full of drums was turned away by Hetero security after being told of the regulatory inspection underway.
The FDA rebuke comes just under a month after Hetero, along with Dr. Reddy’s, inked an agreement with the Gates Foundation to bolster wider patient access to Yeztugo, Gilead Sciences' twice-yearly HIV pre-exposure prophylaxis.
Editor's note: The headline of this story was updated to more accurately convey the tone of the FDA's communication.