Six months after the FDA banned a Micro Labs plant in India for a variety of quality issues, the drugmaker is recalling nearly 55,000 bottles of generic Lipitor from another of its facilities for having failed impurities testing.
The drugmaker has recalled 6 lots of simvastatin tablets in different dosages, according to the most recent FDA Enforcement Report. They were manufactured at a plant in Goa, according to the FDA. The recall is being handled by Micro Labs' U.S. operation out of Princeton, NJ.
The FDA banned the Micro Labs plant in Bangalore in September. Then in a warning letter published last month, the agency laid out a host of problems at the facility. Inspectors had discovered employees had been making "test samples" of drug batches but then ignored out of spec tests when it decided to release the batch. It was also criticized for not putting controls on computerized equipment to prevent employees from deleting failed test results.
The same kinds of data integrity issues have undermined a host of Indian drugmakers, including some of the country's largest, companies like Ranbaxy Laboratories, Sun Pharmaceutical and Wockhardt. Plants operated by all of the companies have been banned for similar drug testing issues that leave open questions about whether the drugs produced there meet quality and efficacy standards.
Wockhardt reported yesterday that in a recent reinspection of its plant in Chikalthana that the FDA had noted the improvements it has made in its data integrity processes and issued no observations in that area. The plant was banned in 2013, in part for data integrity shortcomings.
- find the recall notices here, here and here
Editor's note: The story was updated to indicate that the recalled simvastatin came from Micro Labs' plant in Goa.