An 11-day inspection resulted in 11 observations by the FDA, including a 'manufacturing process that lacked assurance of product sterility.'
A rare strain of bacteria found in recalled eyedrops has been linked to dozens of infections, as well as cases of vision loss, surgical removal of eyeballs and one death.
The manufacturer of eye drops that have been linked to an outbreak of serious bacterial infections in the US, including at least three deaths, did not follow proper protocol to prevent contamination of its products, according to an inspection report published Friday by the US Food and Drug Administration,The FDA visited a Global Pharma Healthcare facility in India for an inspection that started in mid-February, two and a half weeks after the company had voluntarily recalled the EzriCare...
EzriCare Artificial Tears product, which is manufactured by Global Pharma Healthcare, is part of an outbreak of a rare and drug-resistant bacteria called Pseudomonas aeruginosa. The particular strain of the bacteria associated with this outbreak had never before been reported in the US. Patients affected by the outbreak reported using different brands of artificial tears, but EzriCare Artificial Tears was most commonly reported.
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