Dr. Reddy’s Laboratories is becoming synonymous with Form 483s from the FDA: Already knocked four times this year, India’s second-largest drugmaker now has a fifth notice to dwell on. This time, it’s for an oncology plant with a history of faults.
In a note to the Bombay Stock Exchange on Tuesday, Dr. Reddy’s acknowledged it received a Form 483 for its generic oncology formulation facility in Duvvada, India. The form followed an FDA audit of the plant that turned up eight observations from the agency, the company said.
Dr. Reddy’s said in a statement it planned to address the FDA’s concerns “comprehensively within the stipulated timeline.”
The newest notice is the second this month for Dr. Reddy’s and the fifth in a particularly ignominious year for the drugmaker.
In early August, the FDA knocked Dr. Reddy’s API plant in Andhra Pradesh with a Form 483 over claims the plant had not thoroughly investigated complaints from customers who reported out-of-spec API orders, microbiological failures and high water content.
FDA investigators also found issues with the plant’s warehouse equipment malfunctioning, inappropriate storage of products and a records system that was hopelessly out of order.
Those observations were common for Dr. Reddy’s: In an inspection of a solid dose plant earlier this year, the FDA found the plant did not do nearly enough to investigate out-of-spec analyses when stability batches were found to contain impurities.
Nowhere are those institutional problems more obvious than Dr. Reddy’s Duvvada oncology plant, despite the facility being upgraded to Voluntary Action Indicated this year—a positive sign given prior failures.
The current Form 483 follows one for the Duvvada plant In October. And in a scathing warning letter in 2015, the FDA raised a number of issues about the potential for contamination at the facility in the way that employees handled vials, and a follow-up inspection in 2017 found more than a dozen issues, some of them repeats.