A pre-approval inspection by the FDA of Dr. Reddy’s Bachupally biologics production facility earlier this month resulted in the drugmaker being issued a Form 483.
The FDA reprimand, which was disclosed in a financial filing (PDF) issued by the company, focuses on five manufacturing deficiencies observed during the inspection, which took place from Sept. 4 to Sept. 12.
The Bachupally facility is located outside of Hyderabad, India.
The company didn’t detail the infractions in its filing, saying only that it plans to address the issues “within the stipulated timeline.”
On Monday, Dr. Reddy's stock price declined slightly in India in the wake of the news. On Tuesday, shares were slightly up.
Issues at Dr. Reddy’s drug manufacturing operations in Hyderabad stretch back several years.
In early 2024, the company was castigated by the U.S. regulatory agency with a Form 483 that outlined three observations seen during a Dec. 2023 plant visit, including poor records-keeping procedures.
Back in 2019, the drugmaker's Bachupally formulation facility was hit with a Form 483 that highlighted 11 FDA violations, which was the same number of observations the agency found at the same plant it inspected in 2017.