are under a ban, around 30% of Canadian and British manufacturing facilities approved by the FDA to supply medicines have been issued an import alert. The FDA data show that 403 Form 483s were issued to Indian facilities since January 2011 to November 2013, with the highest number of 155 in 2012. The data include adverse reports issued to drug manufacturers, food product makers and bio-research monitoring individuals.
“Observations are made when in the investigator’s judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health,” the USFDA guidelines state.
The USFDA does not make public the details or issuance of a Form 483 while companies have seldom disclosed the receipt of this document. No details of the alleged violations were provided to FE.
A Form 483, theoretically, is a precursor to a warning letter, if the issues identified during an investigation remain unresolved. A warning letter may lead to an import alert if the violations continue to remain serious and the regulator anticipates them to pose a significant risk to US citizens.
Sun Pharmaceuticals Industries, India’s largest drug firm by sales, received five Form 483 in the period mentioned above, four of them in 2012. Sun Pharma’s Karkhadi facility located in Gujarat, inspected in November 2013, was the latest Sun facility to get a warning letter.
“The issuance of a Form 483, or a list of observations, is a usual practice after the USFDA completes its inspection of a plant. This includes all types of observations as may be appropriate for the facility. As a company with a long-term interest in the US pharmaceutical market, we remain compliant at all times and close out the 483s as soon as possible, either internally or along with an external consultant as may be appropriate,” Sun Pharmaceutical said, when asked about whether the issues identified in its facilities were resolved as on date.
Sun Pharma’s Caraco facility in Detroit had received a warning letter