Piramal gets FDA resolution at Kentucky plant as it begins production in Michigan

After being handed a citation from the FDA for substandard manufacturing conditions at a plant in Kentucky, Piramal Pharma now says the case is closed.

In a filing with the Bombay Stock Exchange, the company said it has received an Establishment Inspection Report from the agency and that the "inspection has now been successfully closed by the US FDA."

FDA inspectors visited the site in December and early January.

Last month, the company said the FDA's Form 483 filing covered six observations, with none being related to data integrity. At the time, the manufacturer said it was "preparing a detailed response."

The FDA issues Form 483s after inspections that uncover possible violations of the Food, Drug, and Cosmetics Act.

In Piramal's case, the observations fell in the "Voluntary Action Indicated" class, which means the FDA found "objectionable conditions" but was "not prepared to take or recommend any administrative or regulatory action." It's not immediately clear exactly how Piramal responded to the FDA's concerns.

Meanwhile, Piramal also announced that it has started producing active pharmaceutical ingredients (APIs) at a manufacturing facility in Riverview, Michigan. That plant, which ended up costing the company $38 million, covers about 25,000 square feet and includes production, warehousing and supporting utilities.

“It brings additional capacity to our North American offering, which we believe satisfies the market's current high demand for APIs,” Peter DeYoung, Piramal chief executive, said in a recent press release. 

Elsewhere, Piramal last year said it would shell out $74.4 million to expand its antibody-drug conjugate and API manufacturing facilities in the U.K.