Indian pharma firm caught shredding documents at 1am by FDA
pharmafile | January 24, 2017 | News story | Manufacturing and Production, Research and Development | FDA, Hetero Labs, observations
Hetero Labs, an Indian pharmaceutical firm, has been observed by the FDA shredding what the FDA judged to be controlled documents, with suggestions that they were batch packaging records and batch manufacturing records.
India has been dogged with suggestions that its manufacturing processes may not be up the level required by the FDA. With the US importing a large number of pharmaceuticals from India, the process of regulating the manufacturing industry in India has been raised accordingly. This has led to numerous stories of a minority of firms experiencing troubles, sometimes due to comical issues, such as a leaky roof, but, at other times, there have been more serious consequences.
The FDA highlighted, in its letter to the company, that they had been observed, via CCTV recording, moving a shredder into the document storage area, precisely four days prior to the FDA’s visit. Once the shredder was in place, workers were observed putting documents through the shredder. Hetero responded that the process had nothing to do with the impending FDA visit and was actually part of a routine cleaning operation.
In total, the FDA’s report made eight observations upon the state of the facility – noting other issues, such as investigations into drug complaints not being able to be found and the cleanliness of the facility not being maintained to the correct levels.
The issues that Indian firms have been having meeting FDA regulation has put pressure on the industry, with the US being a major export market and any hold that is placed on the export of pharmaceutical goods placing a strain on the company involved. It has led to something of a back and forth between the companies and the FDA, as the companies attempt to clear the issues, invite the FDA back only to have further issues found. With this being said, India is still home to the most FDA-approved plants outside of the US.
Ben Hargreaves
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