The FDA called out Indian API manufacturer Vamsi Labs for failing to complete investigations at its Solapur, Maharashtra facility, including one for API batches shipped to the U.S.
The agency’s March inspection found that the firm failed to investigate batches that did not meet stability requirements. The inspector also noted that a complaint investigation was started after foreign particles were found in a drum of API product. However, the facility did not go beyond retention sample testing and didn’t justify cutting the investigation short.
A deviation investigation in May 2017 did not properly test water microbiological samples after the company missed a sanitation cycle of a water system. The firm “did not collect microbiological water samples prior to cleaning the system when the previously scheduled sanitation cycle was not run,” the agency said.
Additionally, the facility’s procedure for microbiological water sampling didn’t explain when microbiological samples should be collected. The inspector observed samples being taken after the sanitation cycle finished and noted that the results “do not show accurate water quality prior to sanitation.”
The agency also found that the firm failed to properly maintain equipment. One building’s heating, ventilation and air conditioning system had fine filters that exceeded predefined ranges for pressure differences, despite a procedure instructing staff to change or clean the filters if they went over the pressure differential limits.