It has been more than a year-and-a-half since the FDA issued a warning letter for two plants in India owned by Aarti Drugs. But the drugmaker has yet to meet FDA expectations and so the agency has now put them on an import alert, banning them from shipping products to the U.S.
The drugmaker made the admission today in a filing with the Bombay Stock Exchange (BSE), saying the alert was issued Monday. The company said that the while the agency banned both plants in Tarapur, that it had delisted one several years ago from being considered FDA-approved. Aarti said following a reinspection in August that it had responded four times to the FDA with how it was making improvements and is awaiting the FDA's official communication on the alert so that that "we can take immediate actions to rectify the same."
The drugmaker said it didn't expect the ban to have much effect on its top line since U.S. sales make up slightly less than 1% of its total.
Aarti did not say what kinds of issues the FDA had raised, but in a warning letter for the two plants issued July 30, 2013 laid out a number of serious concerns. The warning letter said the company's quality-control laboratory documentation practices didn't give the agency any assurance that test results were reliable. Employees had noted completion times in batch records for processes that hadn't finished, and tests were run based on experience rather than written procedures. The FDA said required raw data was missing from some test reports and the audit trail function on chromatographic systems had been disabled so it couldn't be collected.
Among other problems noted by inspectors was the fact that in 2012 the company recorded 130 power interruptions during processing but never once did quality officials investigate whether the power interruptions affected samples in the quality-control stability chamber.
Aarti of course joins a long list of Indian drugmakers that currently have plants banned, all for issues that include questions about drug testing procedures that leave the FDA with concerns about the quality and effectiveness of the drugs they have shipped to the U.S. Four plants operated by Ranbaxy Laboratories, which has just merged into Sun Pharmaceutical, along with Sun itself, an Indian plant operated by Apotex, and two plants operated by Wockhardt, are all on the FDA import alert list. FDA officials were recently in India signing cooperation agreements and talking with Indian drugmakers there about the agency's views on the need to establish quality approaches that can meet its expectations.
- here's filing with the BSE
- here's the July 2013 warning letter