Indian drug maker Wockhardt announced it had been warned about operations at Morton Grove in a filing on the Bombay Stock Exchange (BSE) on March 1.
The firm did not provide details of the warning but did say it “already initiated appropriate measures since last several months to address the issues.”
The newly published letter sets out both the observations made by the US Food and Drug Administration (FDA) inspection team that visited in February 2016 and the agency’s reaction to Wockhardt’s subsequent remediation efforts.
For example, while the agency acknowledged receipt of an updated investigation into batch stability failures, it said the response was inadequate because it does not make clear why the problem was not examined in the first instance.
"Your company’s inadequate oversight"
The FDA also pointed out that the Morton Grove facility joins a list of Wockhardt plants that it considers to be non-GMP compliant, which it said is indicative of company-wide failings.
“At this time, seven Wockhardt facilities including Morton Grove are considered out of compliance with CGMP. These repeated failures at multiple sites demonstrate your company’s inadequate oversight and control over the manufacture of drugs.”
“In your responses to the various actions listed above, including during multiple meetings with FDA, you have repeatedly discussed and promised corporate-wide corrective actions. Yet, when FDA inspects or returns to other Wockhardt facilities, similar violations are shown to persist.”
The agency called on Wockhardt to address the problems.
"You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements."
Wockhardt did not respond to a request for comment.