An API maker in Chennai, India, has been dealt a double whammy by the FDA, which has issued it a warning letter after first banning import of its products into the U.S.
The FDA’s concerns with Malladi Drugs & Pharmaceuticals centered on the potential for contamination of the APIs it makes. Inspectors found that containers used in production were hard to clean and often left with water standing in them, the warning letter says.
Some of the manufacturing area was also open to the outdoors, and the warning letter noted “vermin, such as birds and insects, in the facility near open equipment used for drug manufacturing.”
In addition, the FDA said the plant’s processes were not validated and batch manufacturing procedures were often changed without any formal process. During the inspection, investigators noted that 24 batches in two years had been rejected for out-of-spec results. Some of these were reprocessed.
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Those observations and others followed a September inspection. In December, the facility was added to the FDA’s import alert list. The FDA suggested Malladi Drugs hire a consultant to help it get its processes up to U.S. standards.
The FDA had made the same suggestion in a February warning letter to Indian API maker Alchymars ICM after an inspection uncovered a host of problems including filthy areas, equipment that was badly in need of repair and a quality-control unit that had failed to inspect customer complaints thoroughly. In that case, some of the observations were repeats from an inspection of the API maker two years earlier.