Updated on 30 July 2013
FDA spokesperson Mr Christopher C Kelly told PTI, "India has been a consistent provider of low-cost and quality medical products for many countries of the world. FDA seeks to ensure that Indian manufacturing facilities importing to the US understand the risks associated with their product's processes and assure they remain compliant to FDA's regulations."
Mr Kelly further added that the FDA has encountered problems like adulteration with contaminants that should not be found in manufacturing units, like microbiological agents like salmonella and listeria, or products identified with unapproved chemicals or pesticides and even presence of filth such as foreign bodies and insect parts.
FDA has further pointed out that issues associated with quality systems implementation, data integrity and validation of various processes used in manufacturing or testing have been found in India's manufacturing units.