FDA Finds Contamination Issues at Eye Drops Plant

Credit: FDA.
US regulators discovered long list of sanitation problems at factory in India that made eye drops linked to outbreak of serious eye infections.

HealthDay News — US regulators inspecting a factory in India that has been linked to contaminated eye drops have uncovered a laundry list of problems. An outbreak of eye infections involving products made at the factory stems from exposure to Pseudomonas aeruginosa. So far, 3 people have died, while there have been 8 reports of lost vision and dozens of infections.

US Food and Drug Administration inspectors were at Global Pharma Healthcare Ltd.’s factory from February 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 the agency’s 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 the 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, CBS News reported.

The 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. “Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals,” the inspectors wrote.

Some testing of the unopened artificial tears early in the outbreak did not find bacteria, but it was found in already-opened bottles. However, the FDA later “found unopened tubes to be contaminated with bacteria,” CBS News reported. The FDA did not say whether the strain of bacteria it found is the same as that seen in the outbreak.

CBS News Article