Eye Drop Manufacturer Warned by FDA on Sterility Lapses Resulting in Blindness, Death
The manufacturer of eye drops linked to more than 80 adverse reactions, including 14 cases of blindness and four deaths, received a 15-page FDA warning letter calling the company out for lack of product sterility as well as inadequate product formulation, data integrity lapses and more.
During a Feb. 20 to March 2 inspection of Global Pharma Healthcare’s facility in Tamil Nadu, India, FDA investigators reported on a Form 483 that there is insufficient validation data to demonstrate that the company’s equipment “can reliably sterilize [redacted] the solution.”
Investigators also noted that the company had “not established that the sterilization process is effective across different manufacturing conditions, such as the pH and temperature of the solution, filtration pressure, flow rate, maximum filtration time, batch size (volume) and effect of sterilization on the filter’s retention capability.” The company has already voluntarily recalled the products and been placed on an import alert to prevent the products from entering the U.S. market.
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