A wave of eye infections in Oklahoma and around the country in early 2022 was likely caused by eyedrops that were contaminated in a foreign pharmaceutical manufacturing facility. That was the conclusion of a U.S. Food and Drug Administration report released on April 3. No sanctions were announced or even suggested in the report, but an official did say that the manufacturer will probably be sent a warning letter for violating FDA standards.
The U.S. Centers for Disease Control and Prevention and the FDA launched an investigation in February 2022 after 68 people were diagnosed with serious eye infections. Eight of those people lost their vision, and three of them lost their lives. The infections were soon linked to contaminated eyedrops, and recalls were announced because the Pseudomonas aeruginosa bacteria that was causing them is resistant to antibiotics.
During the course of the CDC and FDA investigation, officials were dispatched to inspect a manufacturing facility in India. During a series of inspections conducted in February and March 2022, the officials found more than 10 problems that led them to describe the manufacturing process they saw as “deficient.” The problems that led to dangerous products being shipped to the United States included:
- Covering walls and floors in materials that could not be easily cleaned and disinfected
- Leaving manufacturing equipment uncovered
- Not checking product package seals
- Conducting only brief visual inspections before shipping products
The manufacturer has not released any statements regarding these findings, and it has directed media questions about them to the American companies that distributed and sold its products.
Consumers pay the price
This pharmaceutical manufacturer does not seem to have taken FDA standards and requirements very seriously, and American consumers paid the price. If the only consequence for releasing a drug-resistant and potentially deadly bacteria and causing blindness and death is a strongly-worded letter, this kind of behavior will likely continue.