[1]micolo j on flickr creative commons
Are the facilities at Unimark Remedies for the birds?
That’s the impression one may gather after reading a warning letter [2] the Food and Drug Administration issued to the company, which is based in India and supplies active pharmaceutical ingredients.
The agency noted that in March 2014 inspectors found evidence of “pests.” More specifically, there was a bird’s nest near the ceiling of a manufacturing building and bird poop in a warehouse. And a lizard was found in another warehouse.
As troubling as these findings may be, the FDA was much more concerned with a laundry list of still more disturbing problems. Notably, the FDA inspectors cited several examples of data integrity issues that raised questions about the quality and reliability of the ingredients.
For instance, Unimark did not assign lab analysts user names and passwords on laboratory computer systems, even though all lab employees had full access to the computers. This meant that data generated to evaluate the quality of active pharmaceutical ingredients went unprotected. As a result, key findings could be deleted or altered, which troubled the FDA.
Meanwhile, recordkeeping was also lacking. Test results often went unrecorded, even as batches of ingredients were on the production line. Employees signed documents verifying production steps they never witnessed or performed. And during the FDA inspection, managers admitted employees created batch records after the manufacturing process took place.
Compounding matters, Unimark failed to make proper use of computer back-up systems to retain data. This was an issue because some records were discarded. In a subsequent communication to the FDA, the company claimed a “probable reason” for missing data “was due to some malfunction in the computer system at the time of data acquisition.”
We reached out to Unimark for comment and will pass along any reply.
This is only the latest instance in which the FDA has scolded an Indian drug maker or ingredients supplier for quality control problems. Over the past several years, there has been growing concern over the veracity of the pharmaceutical supply chain after the agency cited several companies for production failures.
The most notable example was Ranbaxy Laboratories, which is now owned by Sun Pharma. The drug maker has been a poster child for manufacturing problems. Last year, Ranbaxy paid a $500 million fine to US authorities as part of a settlement that included pleading guilty to two charges of violating drug safety laws that, for example, involved manipulating data.
Several companies have also been hit with so-called import alerts in which the FDA bans products made at a specific facility. The crackdown, however, has alarmed Indian drug makers. They have complained the FDA has singled them out for especially tough inspections, which occur too frequently and haphazardly, depriving them of the opportunity to make substantive changes.
Earlier this year, the FDA began considering a new approach to inspecting manufacturing facilities in India. The plan is to “allow our inspectors to document where a firm’s quality management system exceeds what would be required to meet regulatory compliance,” FDA officials wrote in a blog post [3] last March. “To put it simply: the inspections can yield also carrots, and not just sticks.”