Federal inspectors have found dirty equipment and clothing, missing safeguards and procedures and dozens of other issues at an eye drops manufacturer in India.
The inspection of Global Pharma Healthcare Pvt Ltd’s site in Tamilnadu came after a multistate outbreak of rare and drug-resistant bacteria linked to eye drops made by the company.
A flurry of US deaths and blindness caused by contaminated eyedrops has caused panic nationwide.
Three Americans have died, eight have suffered vision loss and four people have had to have their eyeballs removed after becoming infected with the deadly strain of bacteria called Pseudomonas aeruginosa.
As of March 14, a reported 68 patients in 16 states 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 eight people losing their vision, and four people who had to have their eyeballs removed
The inspection, which took place between February 20 and March 2, appears to be the US Food and Drug Administration’s (FDA) first visit to the company’s plant in India.
The FDA said in the document: ‘You used a manufacturing process that lacked assurance of product sterility.’
Poor cleaning throughout the factory as well as significant gaps in written procedures and training for employees were also found.
Surfaces that touched packaging ‘were not cleaned, sanitized, decontaminated, or sterilized’ and there were gaps or mismatches in records to do with how key machines and areas were cleaned.
Surfaces were not easy to clean, as one room had ‘soft, unsmooth, and cracked sealant, protruding nails, and nail holes’ on the walls.
The company also did not track or have rules on how many times sterile overalls could be re-used in the company’s cleanroom after washing — where the eye drops are manufactured.
The booties worn by workers were noted to be ‘discolored and worn-out’.
An inspector also saw a ‘black, brown, greasy deposit’ on part of one of the company’s machines used to put its product into bottles.
Global Pharma Healthcare Pvt Ltd was found to have skipped important tests to double check the its products were sterile.
It also failed to verify the ingredients it used to make the products, relying only on what its supplier said.
The FDA wrote: ‘Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals.’
The bacteria was found lurking in EzriCare and Delsam Pharma eyedrops, which have been recalled while health officials investigate.
Most patients reported using 10 different brands of artificial tears, but EzriCare Artificial Tears, a preservative-free, over-the-counter product, was the brand most commonly reported.
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 using EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears.
Last month, the manufacturer Global Pharma recalled the drops that had been sold at major drug stores across the country, including Walmart, Target, and CVS, and on Amazon.
It issued a second recall later in February of Delsam’s Artificial Eye Ointment ‘due to possible microbial contamination.’
A possible cause of the contamination is a lack of preservatives in the EzriCare and Delsam Pharma’s artificial tears.
The FDA said the company failed to adequately test its products for bacterial contamination and packaged them without adequate preservatives, a safeguard for products to prevent the growth of bacteria in the event of contamination.
Earlier this month, two other companies recalled some of their products. Florida-based Apotex voluntarily recalled six lots of its prescription Brimonidine Tartrate Ophthalmic Solution, 0.15 percent on March 1 because at least four bottle caps developed cracks, jeopardizing their sterility.
And on March 3, Pharmedica recalled its Purely Smoothing 15 percent MSM Drops ‘due to non-sterility.’
The CDC said that 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 from as far back as May 2022. The agency is continuing to test unopened bottles.
The agency still does not know if the drops were contaminated during the manufacturing process or after they left the factory, possibly due to cracked caps that let in dangerous bacteria.