The FDA called out Indian API manufacturer Vamsi Labs for failing to complete investigations at its Solapur, Maharashtra facility, including one of 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.