After a year of remediation, an Indian drugmaker has worked its way out from under an FDA warning letter issued for its sterile injectables operation.
The FDA last week sent a closeout letter for USV Private’s finished pharmaceutical injectables plant in Dabhel, Daman, in India.
The FDA said an evaluation of USV’s corrective actions appear to “have addressed the violations contained in this Warning Letter,” but noted that it would continue to monitor the plant to assure it stays that way.
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The FDA in March 2017 issued the warning letter after finding a list of issues, including with the plant’s microbiology testing lab and how it was investigating out-of-spec results. The agency also noted computer access issues after uncovering 25 deleted test results in the audit trails of two pieces of equipment.
The FDA at the time acknowledged the fact that USV had hired a consultant to help it audit the plant’s processes. Still, it issued the warning letter anyway because some of the issues were the same ones that had been included in a warning letter for USV’s finished pharmaceutical plant in Mumbai in 2014, and so the company should not have repeated them.
The Mumbai plant continues to operate under the overhang of that warning.