FDA Finds Dirty Equipment and Lack of Safeguards at Eye Drops Factory Amid Deadly Outbreak
U.S. inspectors found dirty equipment and other issues at an eye drops factory as officials investigate a serious outbreak of bacterial infections, some of which have led to deaths.
U.S. Food and Drug Administration (FDA) inspectors saw “black, brown colored greasy deposit” on one machine and found the machine had not been cleaned for weeks, according to documents made public by the FDA about five weeks after a Feb. 21 inspection of the factory. (pdf).
Inspectors also said Global Pharma Healthcare Pvt Ltd, which runs the factory in India, failed to properly sterilize equipment, perform aseptic techniques, and ensure products were sterile.
“You used a manufacturing process that lacked assurance of product sterility,” inspectors said in one of the documents. In another, they said that the factory had areas that were hard to clean, writing that they saw “cracked sealant” and “protruding nails.”
Inspectors also saw that clothing used in cleanrooms were reused after washing, with no clarity on how many times the articles were reused. They recorded discolored overalls and discolored and worn-out booties being used in the cleanrooms.
Global Pharma Healthcare Pvt. Ltd. did not return a request for comment.
The inspections were completed between Feb. 20 and March 2.
Recalls
Global Pharma Healthcare recalled the eye drops, known as artificial tears, in February after U.S. officials advised the drops might be contaminated and linked to an outbreak of drug-resistant bacteria. Another eye product, an artificial (tears) ointment, was recalled later in the month at the prompting of the FDA.
The FDA has said it recommended the recalls due to violations of good manufacturing practice, including the lack of adequate microbial testing.
The Artificial Tears Lubricant Eye Drops are distributed by EzriCare LLC and Delsam Pharma.
The Artificial Eye Ointment is distributed by Delsam Pharma.
The former has been linked with an outbreak of drug-resistant bacteria in the United States. The latter was recalled because the FDA found some of the products were “leaking when the cap is opened,” according to Global Pharma Healthcare. There was suspicion the ointment could result in eye infections, though no adverse events had been reported.
Outbreak
Pseudomonas aeruginosa, the bacteria, has been recorded in 68 patients across 16 states, according to the U.S. Centers for Disease Control and Prevention (CDC).
Three of the patients died. Eight reported loss of vision. There were four cases of surgical removal of an eyeball.
Most patients reported using artificial tears. The artificial tears originating with Global Pharma Healthcare was the most commonly reported brand used among over 10 brands that the patients reported using. Laboratory testing confirmed the presence of the bacteria in opened EzriCare bottles. The CDC said it is testing unopened bottles to evaluate “whether contamination may have occurred during manufacturing.”
People were urged to stop using the artificial tears, which can be purchased over the counter, and to consult their doctors if they already used them and are experiencing problems. Eye infection symptoms include eye pain, redness, and blurry vision.
