The hits just keep on coming for India manufacturing giant Lupin as it continues to run afoul of the FDA.
In a regulatory filing late last month with the Bombay Stock Exchange, the drugmaker said it received a Form 483 notice from the FDA citing problems at its injectables facility in Nagpur. The notice flagged five observations and came after a preapproval inspection of the site from Oct. 17 to Oct. 29.
“We are committed to addressing the observations at the earliest and gaining approval for injectable manufacturing for the U.S.,” Lupin wrote in the filing.
It was the third time in the span of five weeks that Lupin revealed a compliance reprimand from the FDA in a regulatory filing.
A warning letter sent to Lupin Sept. 27 and posted on the FDA website Nov. 1 revealed that the company had ceased manufacture of products bound for the U.S. from its active pharmaceutical ingredients plant in Tarapur.
A month ago, the FDA pinged (PDF) Lupin’s biosimilars plant in Pune, identifying a whopping 18 observations from an inspection conducted from Oct. 3 to Oct. 14.
In addition to a wide range of quality control and cleaning issues, the regulator cited a failure to investigate customer complaints of discolored product. The agency also flagged inadequate safeguards against decontamination and inadequate apparel by workers to prevent potential contamination.
These are three of 12 plants Lupin runs in India. The Tarapur site employs 1,200 people and the Pune plant has 520 workers. The Nagpur plant employs roughly 900 people and produces more than 8 billion units of pills annually. That site is in the process of gearing up for production of injectables.