In June 2020, Senator Chuck Grassley, Republican of Iowa, held an oversight hearing on the F.D.A.’s foreign inspection process, noting that the plants were given 12 weeks’ advance notice, “plenty of time to doctor up a facility to make sure that it passes inspection.” The agency has since received budget authority to conduct unannounced overseas inspections.
The F.D.A. paused overseas inspections during the height of the coronavirus pandemic, and the number of foreign inspections remained low last year, at 684 compared with 3,272 in 2019, according to agency data.
The F.D.A. has 4,000 overseas facilities to inspect, with about 20 percent in India; one of its six inspector positions in that country was vacant in late 2021, according to a report issued last year by the Government Accountability Office.
For over-the-counter drugs, the F.D.A. uses a system that essentially lists a medication recipe. Companies can make the products without express agency approval but are expected to follow agency rules for manufacturing quality products, said John Serio, lawyer with Withers Worldwide who has pharmaceutical clients.
“If you’re not out there inspecting facilities,” Mr. Serio said, “these sorts of problems will crop up because there’s no threat that if you’re out of compliance that the inspector will come knocking at your door.”
Dr. Vicente Diaz, the chief of ophthalmology at Yale Health Plan in Connecticut who specializes in infectious diseases, said the infections evading the “big gun” antibiotics had alarmed experts. He worries that if doctors use ineffective antibiotics for too long or wait to culture a bug, “that gives the bacteria more time to multiply and get more aggressive,” he said.
EzriCare drops do not contain preservatives, a fact that Dr. Diaz found troubling. He said he had never seen another reusable eye product without preservatives or other safety features to limit bacterial growth. Preservative-free drops usually come in single-use bottles, given the risk, he said.
“I’m surprised that formulation was allowed to go on the market without more scrutiny,” he said. “It’s kind of like the perfect storm.”
