FDA inspectors keep hitting replay for Dr. Reddy’s Laboratories plants as they make their way through its manufacturing sites. They cite a facility and move on only to find India’s second-largest drugmaker making essentially the same missteps at the next facility they check.
The agency this week posted a Form 483 (PDF) for a Dr. Reddy’s API plant in Andhra Pradesh based on an inspection that had been completed just a couple of weeks before. It came just weeks after the company had been issued an 483 (PDF) for a finished products facility in the same state. It was the drugmaker’s fourth Form 483 this year.
This time around, the agency offered up five observations, most of which centered around the fact that the plant had not thoroughly investigated complaints from customers who find the APIs they bought are out of spec when they do acceptance testing. Among issues were microbiological failures and high water content.
Dr. Reddy’s tried to explain the water issue by citing high humidity in the facility, but inspectors found that unpersuasive because humidity readings were all over the place in the plant, low to high. There were also issues with equipment malfunctioning in a warehouse that could lead to product mix-ups and products that were not being stored appropriately. Records were generally a mess and couldn’t be provided expeditiously when requested.
None of this is new for Dr. Reddy’s, which has been making the same kinds of mistakes across a variety of manufacturing operations for years now. Some of the issues have resurfaced at the same facilities on FDA return visits.
For example, an inspection of a solid dose plant earlier this year found the plant did not do nearly enough to investigate out-of-spec analyses when stability batches were found to contain impurities.
Three years ago, the FDA issued a sweeping warning letter that blasted the drugmaker for big problems found at three facilities, including the discovery of a secret lab where one plant did tests that were not reported to the FDA.
One of those facilities, Dr. Reddy’s long-troubled oncology formulations plant in Duvvada, India, was upgraded this year to Voluntary Action Indicated, one bright spot in an otherwise dark regulatory period for the company.
The most recent citation comes as the company this week reported quarterly earnings showing a 3% rise in revenues, including in North America, but a 45% jump in earnings per share. That was boosted by a $50 million payment from Celgene tied to a patent dispute over generic Revlimid capsules in Canada.
The company also reported that co-chairman GV Prasad will hand off the CEO role to Chief Operating Officer Erez Israeli Aug. 1.