15/16 June 2023
In early August, the Indian manufacturer Emcure Pharmaceuticals Ltd. received a warning letter from the FDA. In this case, the background was an inadequate analysis of the causes of deviations within the scope of the sterility test. Emcure had indicated "laboratory errors" as the cause of the positive sterility control, but failed to substantiate this finding. At the same time, possible production causes were insufficiently investigated. The FDA summarized this as follows:
It is also interesting to note that the microorganisms detected in the sterility test were not only found in the laboratory environment (which led to the "laboratory error" analysis) but were also detected within the production areas in the previous months. Accordingly, a comprehensive analysis of the manufacturing conditions would have been necessary. In this context, the FDA draws particular attention to the special risks of the sealing process and the "Container Closure Integrity", as deviations and recalls had already occurred in the past.
It is worth noting that the same company had already received a warning letter in 2016 in which the following issues were listed:
As a whole series of errors in the area of production were already recorded at that time, it would have made sense to investigate the aseptic nature of the production processes, the aseptic behaviour during production and the associated contamination possibilities.
Further details can be found in the latest Warning Letter and the Warning Letter from 2016.