FDA conducts inspection of facility linked to fatal eye drops, identifies multiple safety issues

By Natalie Kruvant | Fact-checked by MDLinx staff
Published April 5, 2023

Key Takeaways

  • Global Pharma Healthcare recalled multiple eye products after contamination with drug-resistant bacteria.

  • Now, the FDA has visited Global Pharma Healthcare's facility in India. There, inspectors found multiple safety risks, including dirty safety gear.

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.[]

Related: Recall alert: More eye products recalled because of contamination

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.[]

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.[]

Related: More fatalities linked to recalled contaminated eye drops

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