Hyderabad: During an inspection of Aurobindo Pharma’s manufacturing facility here, the US Food and Drug Administration found it to be infested with rodents and other insects, its staff poorly trained and its equipment not well maintained. The audit was conducted on February 12 and 20.
The US FDA said in its report that equipment used in the manufacture, processing, packing and holding of drug products is ‘not of appropriate’ design to facilitate operations for its intended use.
The Unit 4 formulation building and manufacturing unitone building was inspected.
The US officials stated that the buildings used for manufacturing, processing, packing or holding of drug products are not free from infestation by rodents, birds, insects and other vermin.
While the officials were walking around the unit, they found a large mosquito in the semi-finished storage area.
The FDA officials also observed that employees engaged in the manufacturing, processing, packing etc., of drug products lacked training for their assigned functions.
Equipment and utensils were not cleaned and sanitised at appropriate intervals to prevent contamination, which altered the safety, strength, quality and purity of the drug products, the FDA observed.
Aurobindo Pharma did not respond to our queries despite several attempts to reach them....