Federal inspectors have found dirty equipment and clothing, missing safeguards and procedures and dozens of other problems at an eye drop manufacturer in India.
The inspection of Global Pharma Healthcare Pvt Ltd’s Tamilnadu site came after a multi-state outbreak of rare and drug-resistant bacteria linked to eye drops made by the company.
A spate of US deaths and blindness caused by contaminated eye drops has sparked panic across the country.
Three Americans have died, eight have lost their sight and four people had their eyeballs removed after becoming infected with the deadly strain of bacteria Pseudomonas aeruginosa.
As of March 14, 68 patients in 16 states are reported to have 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 were diagnosed with infections from the bacteria in EzriCare, which has caused three deaths and caused eight people to lose their sight, and four people who had to have their eyeballs removed
The inspection, which took place between Feb. 20 and March 2, appears to be from the U.S. Food and Drug Administration (FDA). first visit to the company’s factory in India.
The FDA said in the document: “You used a manufacturing process that did not guarantee the sterility of the product.”
There was also poor cleaning throughout the plant and significant gaps in written procedures and employee training.
Surfaces that came into contact with packaging ‘were not cleaned, sanitized, decontaminated or sterilized’ and there were gaps or discrepancies in data on how key machines and areas were cleaned.
Surfaces were not easy to clean, as one room had “soft, uneven and cracked caulk, protruding nails and nail holes” in the walls.
The company also didn’t track or have rules on how many times sterile coveralls can be reused after washing in the company’s cleanroom – where the eye drops are manufactured.
The slippers worn by workers were found to be ‘discolored and worn’.
An inspector also noticed a “black, brown, greasy deposit” on part of one of the company’s machines that bottled the product.
Global Pharma Healthcare Pvt Ltd was found to have skipped important tests to verify that its products were sterile.
It also didn’t verify the ingredients it used to make the products, relying only on what its supplier said.
The FDA wrote, “Your company has not conducted at least one test to verify the identity of each component of a drug. Your company has also failed to validate and establish your parts supplier’s test analytics at appropriate intervals.”
The bacteria was found lurking in eye drops from EzriCare and Delsam Pharma, which have been recalled as health officials investigate.
Most patients reported using 10 different brands of artificial tears, but EzriCare Artificial Tears, an over-the-counter product with no preservatives, was the most reported 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 Artificial Tears and Delsam Pharma’s Artificial Tears.
Last month, the manufacturer Global Pharma recalled the drops sold at major drugstores across the country, including Walmart, Target and CVS, and on Amazon.
It issued a second reminder later in February of Delsam’s artificial eye ointment “because of possible microbial contamination.”
A possible cause of the contamination is a lack of preservatives in the artificial tears of EzriCare and Delsam Pharma.
The FDA said the company failed to adequately test its products for bacterial contamination and packaged them without adequate preservatives, a guarantee for products to prevent the growth of bacteria in the event of contamination.
Earlier this month, two other companies recalled some of their products. Apotex from Florida voluntarily recalled six lots of the prescription brimonidine tartrate ophthalmic solution, 0.15 percent on March 1 because at least four caps showed cracks, endangering their infertility.
And on March 3, Pharmadica recalled it’s purely smoothing 15 percent MSM drops “because of non-sterility.”
The CDC said it found the drug-resistant strain of P. aeruginosa in open bottles of the EzriCare drops that researchers collected from patients both with and without infections as of May 2022. The agency is continuing 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, possibly from cracked caps that let in dangerous bacteria.