The F.D.A. has not said how much of the product made by Global Pharma Healthcare in Chennai, India, was imported.
However, records provided to The New York Times by Panjiva, the supply chain research unit of S&P Global Market Intelligence, show that Global Pharma sent U.S. distributors four shipments in 2021 and 2022 amounting to tens of thousands of half-ounce bottles of EzriCare artificial tears.
While the F.D.A. requires a pre-approval inspection of plants that manufacture prescription drugs, there is no such mandate for those that make over-the-counter medicines like artificial tears. Compounding the problem, the number of inspections the agency conducts has plummeted since the pandemic began.
Representative Rosa DeLauro, Democrat of Connecticut, expressed concern about the F.D.A.’s ability to oversee what she described as “substandard safety practices” at U.S. and foreign plants, and called for providing the agency with more funding and greater authority to recall products. “Lives are at stake,” she said in a statement.
On Jan. 3, the F.D.A. blocked Global Pharma’s imports, saying the company had provided “an inadequate response to a records request” and violated manufacturing rules. Shannon P. Hatch, a spokeswoman for the agency, said that the import alert was unrelated to the outbreak.
The F.D.A. also said it recommended a voluntary recall on Feb. 2 over a “lack of appropriate microbial testing,” formulation issues and the absence of proper controls around tamper-evident packaging. The agency conducted an unannounced inspection at the India plant from Feb. 20 through March 2 and found a litany of problems with the plant’s sterility practices, according to an inspection report that was first reported by STAT news.
Clean-room operators were not qualified for the job, and they wore discolored and worn-out foot covers, the report said. An inspector noted “a black, brown colored greasy deposit” on machinery in a room where bottles were filled with the eye drops. One worker acknowledged to an inspector that there was no procedure for cleaning one of the filling machines, according to the report.
