The U.S. Food and Drug Administration (FDA) found several issues at Global Pharma Healthcare's facility in India where it manufactured the recently recalled eye drops.
As of March 14, nearly 70 patients in 16 states have been infected with a "rare strain" of Pseudomonas aeruginosa, 37 of which were linked to four health care facility clusters, according to the Centers for Disease Control and Prevention .
Federal officials also said the company "lacked a clear and specific written procedure for aseptic interventions performed." Aseptic is when something is free of contamination. The company also "did not track or have studies to show how many times" clothing could be re-used by workers, the FDA said. Investigators also noticed that the booties workers used at the facility were "discolored" and "worn-out.
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