The Food and Drug Administration says it found a host of problems at an Indian manufacturing plant recently linked to contaminated eyedrops
is considered particularly worrisome because the bacteria driving it is resistant to standard antibiotics.
The report has the agency’s preliminary findings and is likely to be followed by a formal report and a warning letter to the company. An FDA spokesman said the inspection indicates that the company’s products “may be in violation of FDA’s requirements.” The FDA is responsible for assuring the safety of foreign products shipped to the U.S., though it has long struggled to keep pace with international pharmaceutical supply chains that increasingly begin in India and China.
The FDA has been investigating the U.S. bacterial outbreak with the Centers for Disease Control and Prevention. CDC officials have detected the bacterial strain in opened bottles of EzriCare drops collected from infected patients. FDA officials are also testing unopened bottles of the drops.
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