Aurobindo Pharma shares fell 3 percent intraday Monday after a media report disclosed disturbing details from the inspection of unit 4 by the US health regulator.
US Food and Drug Administration officials found a ‘large female mosquito’ in a facility of Aurobindo Pharma during inspection, which, according to them, was not ‘free of infestation by rodents and other insects’.
The US FDA had issued nine observations after inspection of the drug maker’s Unit 4 formulation facility during February 12-20.
“Building used in the manufacturing, processing, packing or holding of drug products are not free from infestation by rodents, birds insects and other vermin,” the USFDA said.
None of the observations are related to data integrity or are repetitive in nature, Aurobindo Pharma had earlier informed the bourses without providing details of the observations.
“We are in the midst of providing a comprehensive response to the observations and would be replying to the FDA within 15 working days from the date of closure (20 February) of audit,” the city-based drug maker had said.
The FDA also observed that employees engaged in the manufacture, process, packing and holding of drug products lack the training required to perform their assigned functions.
“Appropriate controls are not exercised over computers or related systems to assure that changes in the master production and control records or other records are instituted only by authorised personnel,” the FDA observed.
Equipment and utensils are not cleaned and maintained and sanitised at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality and purity of the drug products, it further said.
Equipment used in the manufacture, processing, packing or holding of drug products is ‘not of appropriate’ design to facilitate operations for its intended design, the FDA said in the report.
At 14:32 hours IST, the stock price was quoting at Rs 580.55, down Rs 11.90, or 2.01 percent on the BSE.moneycontrol