The FDA warned generic drugmaker RIJ Pharmaceuticals for multiple violations at its Middletown, New York facility, including inadequate water quality.
The agency inspected the facility in April 3-13, 2018 and found that the water system contained excessive levels of microbiological activity. “High bioburden or objectionable microbes in the water used as an ingredient in your drugs may pose significant risk to consumers,” the agency said.
The firm failed to adequately show that its microbiological test methods could recover pathogenic microorganisms in its finished drugs. It did not adequately test finished product for B. cepacia, a human pathogen that can cause pneumonia in vulnerable patients. The pathogen was found in the water system.
The facility also neglected to test all its drugs for impurities and to verify its test methods—such as a finished product potency test for its acetaminophen elixir.