The FDA has slapped Piramal with a Form 483 write-up, citing three observations from an inspection conducted from Jan. 29 to Feb. 6 at its active pharmaceutical ingredient (API) plant in Riverview, Michigan.
The Mumbai, India-based CDMO reported (PDF) the notice in a regulatory filing on Wednesday, saying the observations were voluntary action indicated (VAI), which means that the agency is not prepared to take administrative or regulatory action. With official action indicated (OAI) observations, administrative regulatory actions are recommended.
Piramal said the observations did not “relate to data integrity,” adding that it's preparing a “detailed response to said observations.” The FDA has not posted the notice on its website.
Piramal’s shares have fallen 4% since it posted the filing.
In 2016, Piramal gained the facility in a $53 million buyout of Ash Stevens to increase its presence in North America. The plant provides commercial and clinical manufacturing.
In 2021, the company revealed a $38 million investment in the facility. Completion of the first phase of the project was announced last year. It added 25,000 square feet and additional production capacity to meet “the high demand for APIs,” Peter DeYoung, CEO of Piramal Pharma Solutions, said in a release.
Piramal also has an API plant in Aurora, Ontario, which the company is expanding under a $30 million investment plan.
The company also operates plants in Sellersville, Pennsylvania, and Lexington, Kentucky. A year ago, the FDA pinged Piramal’s Kentucky facility, with a Form 483, citing six observations, which Piramal quickly resolved.