(HealthDay News) – U.S. regulators inspecting a factory in India that has been linked to contaminated eyedrops have uncovered a laundry list of problems. An outbreak of eye infections involving products made at the factory stems from exposure to a highly drug-resistant bacteria known as Pseudomonas aeruginosa. So far, three people have died, while there have been eight reports of lost vision and dozens of infections. U.S. Food and Drug Administration inspectors were at Global Pharma Healthcare Ltd.’s factory from Feb. 20 through March 2, where they identified dirty equipment and clothing, as well as a lack of other safeguards. The FDA issued citations to the company after what appears to be their first-ever visit to the plant. “You used a manufacturing process that lacked assurance of product sterility,” the FDA said in the citation document. Artificial tears drops and ointment involved include those branded as EzriCare and Delsam Pharma. Those products have already been recalled. Among the many problems identified by the FDA were that surfaces touched by product packaging “were not cleaned, sanitized, decontaminated or sterilized.” A machine used to fill product into bottles had a “black, brown greasy deposit” on one of its parts, though company logs said the machine had been cleaned weeks before and not used since. Records about cleaning of filling machines and spaces also had gaps and discrepancies,… read on > read on >

















