Federal inspectors discovered dirty equipment and clothing, missing safeguards and dozens of other issues at an eye drops factory in India.
The inspection of the Global Pharma Healthcare Pvt Ltd site in Tamil Nadu came after an outbreak of rare, drug-resistant bacteria linked to eye drops made by the company.
A wave of deaths and blindness in the United States due to contaminated eye drops has caused panic across the country.
Three Americans have died, eight have gone blind, and four people had to have their eyeballs removed after they became infected with the deadly strain of bacteria called Pseudomonas aeruginosa.
As of March 14, 68 patients in 16 states had been infected with this rare strain of Pseudomonas aeruginosa, according to the Centers for Disease Control and Prevention (CDC).
The Centers for Disease Control and Prevention (CDC) says 68 people in 16 states have been diagnosed with infections from the bacteria in EzriCare, which caused three deaths, eight people lost their sight, and four people who had to have their eyeballs removed.
The inspection, which took place between February 20 and March 2, appears to have been under the control of the US Food and Drug Administration (FDA). First visit for the company’s factory in India.
The Food and Drug Administration said document: “I used a manufacturing process that lacks a guarantee of product sterility.”
Poor cleaning was also found throughout the plant as well as significant gaps in written procedures and staff training.
Surfaces that have come into contact with the packaging “were not cleaned, sanitized, disinfected, or sterilized” and there were gaps or mismatches in the records relating to how machines and key areas were cleaned.
The surfaces were not easy to clean, as one room had “soft, slick, cracked sealant sticking out nails and nail holes” on the walls.
The company also didn’t track or have rules about how often sterile cloths can be reused in the company’s cleanroom after washing — that’s where the eye drops are made.
It was noted that the stockings worn by the workers were “mutilated and worn out”.
An inspector also saw “black and brown greasy deposits” on part of one of the company’s machines used to bottle its products.
Global Pharma Healthcare Pvt Ltd has been found to have passed important tests to double check that its products are sterile.
It also failed to verify the ingredients it used to make the products, relying solely on what its supplier said.
The FDA writes: Your organization has failed at least one test to verify the identity of every ingredient in a drug product. Your company also fails to validate and substantiate the reliability of component supplier testing analyzes at appropriate intervals.
The bacteria was found lurking in EzriCare and Delsam Pharma eye drops, which were recalled during health officials’ investigation.
Most patients reported using 10 different types of artificial tears, but EzriCare Artificial Tears, a preservative-free, over-the-counter product, was the most popular brand.
The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) first issued a warning to the public in January against the use of EzriCare and Delsam Pharma’s artificial tears.
Last month, manufacturer Global Pharma recalled drops that were sold at major drug stores across the country, including Walmart, Target, CVS, and on Amazon.
issued call back Later in February, Delsam’s Artificial Eye Ointment was removed “due to possible microbial contamination.”
One possible cause of contamination is a lack of preservatives in EzriCare and Delsam Pharma artificial tears.
The FDA said the company failed to adequately test its products for bacterial contamination and packaged them without adequate preservatives, a product protection to prevent bacterial growth in the event of contamination.
Earlier this month, two other companies pulled some of their products. Florida-based Apotex He was called up voluntarily Six pieces of Brimonidine Tartrate Ophthalmic Solution, 0.15 percent on March 1st because at least four bottle caps showed cracks, threatening their sterility.
And on March 3, Pharmedica He remembers Its pure softener drop is 15 percent MSM “due to non-sterility.”
The CDC said it has found a drug-resistant strain of P. aeruginosa in opened bottles of EzriCare eye drops that researchers have collected from infected and uninfected patients since May 2022. The agency continues to test unopened bottles.
The agency still doesn’t know if the drops were contaminated during the manufacturing process or after they left the factory, perhaps because cracked caps allowed dangerous bacteria to enter.
