Global Health Pharma’s Indian Facility Flagged Down by the FDA for Deficient Manufacturing Process

After two US-based distributors, Delsam Pharma and EzriCare recalled Global Health Pharma’s eye drops in February due to links with an extremely drug-resistant strain of bacteria known as Pseudomonas aeruginosa (the exact strain is called VIM-GES-CRPA), the Food and Drug Administration (FDA) led a 10-day visit to the company’s Indian facility that revealed many issues with the manufacturing process.

The announcement for the first recall was made in early February, and two weeks later, a team of FDA inspectors arrived at the Thiruporur, Tamil Nadu facility in India in what is dubbed the agency’s first visit to the plant.

Observations of Sanitary Conditions in Global Health Pharma’s Indian Facility

• 11 observations were made during the visit
• Focused on worrisome sanitary conditions
• Floors, walls, and ceilings are not easily cleanable
• Nails protruding off surfaces in some instances
• Problems identified with container closures and filters
• Cracked sealant found in the filling room
• No covering or wrapping over filling machine equipment

In a report shared by the FDA in early March, concerns regarding product sterility were also raised. The manufacturing process was considered deficient because the only procedure for ensuring that the bottles of eye drops were properly sealed was through a visual inspection. No other rigorous procedures were deployed to ensure that there was no leak.

Batches produced by Global Health Pharma between December 2020 and April 2022 that were shipped to the US were particularly at risk.

The report is only a preliminary assessment of the situation that is to be followed by a final report and a warning letter that is to be issued to the company.

Additionally, the company was also said to be in violation of the FDA’s requirements as the plant lacked established written procedures for equipment maintenance and cleaning. The testing process for the product was also considered inadequate by the agency.

As more and more pharmaceutical supply chain businesses are moving abroad to places like India and China, the FDA has been having a hard time assuring the safety of foreign products shipped to the US. The pandemic further exacerbated this situation as travel restrictions meant that inspection of foreign plants had to be carried out remotely instead of in-person inspections, leading to a backlog of delays.

As of the second week of March, over 65 cases of infection across 16 states have been attributed to the eye drops. The outbreak has led to 3 deaths, 8 cases of vision loss, and 4 instances where eyeballs had to be surgically removed.

The bacteria is also particularly dangerous because it is resistant to general antibiotics, which is why the FDA is urging consumers to stop using these products. Since the germ causing the infection is known to spread rapidly, the FDA is recommending healthcare facilities follow strict infection-control recommendations when treating affected patients.

The Centers for Disease Control and Prevention (CDC) has joined hands with the FDA to investigate the bacteria and has shared concerns over the number of cases being reported increasing over the coming months

Also, Read;  Apotex to recall glaucoma drug after sterility concerns