An outbreak of eye infections involving products made at an Indian factory has resulted in deaths, loss of vision, and it is apparently caused by eye drops.
The Artificial eye drops and ointment involved include those branded as EzriCare and Delsam Pharma. Recently, these products have already been recalled.
Eye Drops Violation
U.S. regulators examining the plant in India have exposed a laundry list of problems. Among those identified by the FDA inspectors were dirty equipment and clothing, lack of other safeguards, and surfaces touched by product packaging “were not cleaned, sanitized, decontaminated or sterilized.”
They also found that 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 the cleaning of filling machines and spaces also had gaps and discrepancies, CBS News reported.
Surfaces appeared to be hard to thoroughly clean. In one example, walls in a filling room had “soft, unsmooth and cracked sealant, protruding nails, and nail holes,” the report said.
Inspectors found booties used in the company’s clean rooms that were “discolored, and worn-out” and the company “did not track or have studies to show how many times” clothing could be reused by workers.
The FDA issued citations to the company after what appears to be their first-ever visit to the plant.
The eye drops company was also apparently not doing some important testing to ensure that the products were sterile or other tests to determine that the ingredients supplied to the company were in fact what they were supposed to be.
The FDA did not say whether the strain of bacteria in the eye drops it found is the same as that seen in the outbreak.
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