FDA conducts inspection of facility linked to fatal eye drops, identifies multiple safety issues
MDlinx Apr 06, 2023
It's been months since the first bottle of EzriCare Artificial Tears and other eye products were recalled because of contamination with drug-resistant bacteria. Now, the Food and Drug Administration (FDA) has examined Global Pharma Healthcare's manufacturing facility in India and has found several safety concerns, including issues with sterility.
"There were no written procedures regarding aseptic techniques and aseptic behaviors. The firm's management stated verbal instructions were given to operators," the report stated.
The report also noted that workers used "discolored" and "worn-out" booties in the facility and cleaning of handles, doors and other areas were "deficient."
The report also described soiled equipment that lacked regular cleaning.
However, India's health ministry sources say that there was no contamination of the eye drops, according to broadcaster NDTV.
India tests of eye drops linked to US deaths show no contamination - NDTV. Reuters.
Recalled products
EzriCare Artificial Tears, Delsam Pharma Artificial Tears and Delsam Pharma’s Artificial Eye Ointment are all manufactured by Global Pharma Healthcare and have been recalled because of a contamination risk.
Outbreak of extensively drug-resistant pseudomonas aeruginosa associated with artificial tears | hai | cdc.
According to the FDA, 68 patients across 16 states have been impacted by the contaminated drops. Three people have died in connection with the drops and multiple people have lost their eyesight.
Outbreak of extensively drug-resistant pseudomonas aeruginosa associated with artificial tears | hai | cdc.
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