After the U.S. recall of eye drops manufactured by India-based Global Pharma Healthcare and other companies, an FDA inspection has brought serious manufacturing issues to light.
Back in late March, the U.S. Centers for Disease Control and Prevention said that it and the FDA were investigating the outbreak of an extremely drug-resistant strain of a bacteria known as Pseudomonas aeruginosa. The specific strain, called VIM-GES-CRPA, had never been reported in the U.S. prior to the recent outbreak.
As of March 14, 68 patients in 16 states had been infected with the bacteria, most of whom reported using a type of eye drops called artificial tears. The outbreak has led to three deaths, eight reports of vision loss and four cases in which surgical removal of the eyeball was necessary.
So how did this happen? The findings from the FDA's inspection of Global Pharma Healthcare's site in Thiruporur, India, offer some answers.
After the company recalled the eye drops in early February, FDA inspectors visited the facility about two weeks later. During a 10-day visit, the team found 11 observations, ranging from problems with filters and container closures to protruding nails and cracked sealant in the filling room.
“You used a manufacturing process that lacked assurance of product sterility,” the FDA’s report, dated March 2, reads. The agency noted that the company used this “deficient” manufacturing process for batches made between December 2020 and April 2022 that were shipped to the U.S.
It also appears that the plant lacked established written procedures for equipment maintenance and cleaning. The company also didn't adequately test its products, the FDA said.
While these issues are coming to light now, the pandemic made it tougher for the FDA to conduct oversight of foreign manufacturers in recent years. Because of travel restrictions, the FDA struggled to complete inspections of foreign plants, leaving a backlog of delays. The agency utilized remote assessments to provide “critical insight,” but that couldn’t be used in place of in-person inspections.
Global Pharma had previously been placed on an import alert by the FDA for providing an “inadequate response” to a records request and for not complying with good manufacturing practice regulations.