Sterile drugs are susceptible to microbial contamination and so the water used to make their ingredients need to be clean. An Indian API maker has been given that message loud and clear in a warning letter issued by the FDA.
The water problem was discovered during an inspection of a CTX Life Sciences API manufacturing facility in Surat, Gujarat in February. The warning letter says that although the company knew its API was intended for a sterile injectable drug, the plant “failed to monitor and control the water used in the rinse steps for endotoxins.”
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The FDA also had issues with the facility's handling of an out-of-spec test result for an impurity. CTX decided the reading must be the result of an equipment error and so invalidated the test result and moved on. The FDA says that was not nearly enough. The facility needed to thoroughly investigate to rule out other possible causes.
A water system that isn’t carefully monitored can lead to serious issues as federal authorities pointed out several years ago. In 2016, an outbreak of Burkholderia cepacia was tracked by the FDA and the CDC to the water system of Florida-based CMO PharmaTech. The company had produced 10 contaminated lots of constipation drug docusate sodium that resulted in 60 people in eight states becoming infected.