India’s growing importance as generic medicine producers and rising compliance problems prompt the FDA to alter its plans for facility inspections.
Until now, FDA’s inspections of Indian pharma plants have always been with prior notice. The surprise checks and aggressive surveillance are being considered because of instances of fabrication of documents and human error in Indian manufacturing units.
In the past nine months, the FDA has expanded its inspection team in India from 12 to 19, and opened two more offices.
