Global Health Pharma Facility Sterilization Issues Spotted: FDA's Discovery

Urian B., Tech Times 04 April 2023, 10:04 pm

The potential dangers of using contaminated eye-care products have become increasingly evident in recent months after several products manufactured by Global Pharma Healthcare have been linked to a deadly outbreak of bacterial infections.

Implications of the FDA Report on Global Pharma Healthcare

According to the story by Fox Business, this has led to federal inspectors conducting an investigation of the company's facility in India where the EzriCare and Delsam Pharma Artificial Tears products were manufactured.

As a result of the report, it has come to light that the company failed to adhere to proper safety protocols which has caused a significant amount of harm as nearly 70 people in 16 states have been affected. Specifically, three people have unfortunately died, eight people have suffered vision loss, and four people have had to have their eyeballs removed.

In February of this year, the US Food and Drug Administration (FDA) released a report on a serious public health issue - the possible links between a deadly bacterial outbreak and two eye drops manufactured by Global Pharma Healthcare, EzriCare and Delsam Pharma Artificial Tears.

Failure to Adhere to Aseptic Protocols & Poor Cleaning & Maintenance of Equipment

The report detailed a long list of failings in terms of manufacturing and sterilization practices at the facility in India that produces the eye drops. It made some concerning discoveries such as the failure to adhere to even basic aseptic protocols, a lack of clear written procedures and poor cleaning and maintenance of equipment.

These failings created the perfect conditions for potentially deadly bacteria to grow, leading to an initial recall of the two products and a multi-state investigation into the outbreak by state and federal health officials.

As of March 14 this year, the outbreak has now infected 69 people across 16 states, 68 according to CNN. Three patients have died and a further 8 have experienced vision loss, and in 4 cases patients have had to have their eyeballs surgically removed.

A Woman's Story: Tragic Consequences of the Delsam Pharma Artificial Eye Ointment Outbreak

The main strain of bacteria identified as the cause of the outbreak is the rare and drug-resistant Pseudomonas aeruginosa, which was the same strain found in open bottles of EzriCare. Laboratory testing also revealed that the recalled Delsam Pharma Artificial Eye Ointment was contaminated with bacteria, per the FDA.

The effects of this viral outbreak on patients and their families have been tragic. Such is the level of concern that one woman who had to have her eye removed as a result of using the eye drops has filed a lawsuit against Global Pharma Healthcare.

The Need for Robust Regulatory Standards to Ensure Quality Safety of Health Products

As this terrible incident shows, it is vitally important for health and medicinal products to be subject to rigorous and detailed standards of production and regulation. Without international standards of cleanliness, safety, and efficacy in place, more outbreaks like this one can be expected.

It is a stark reminder that the safety of consumers must always be the top concern for healthcare companies. Those who do not take proper care can be held accountable for any damage that is caused.