New Delhi: US Food and Drug Administration officials found a ‘large female mosquito’ in a facility of Aurobindo Pharma during the inspection, which, according to them, was not ‘free of infestation by rodents and other insects’.
The USFDA had issued nine observations after inspection of the drug maker’s Unit 4 formulation facility near here last month.
The audit was conducted between 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.”
“Specifically during the walkthrough of the facility on February 12, 2018, a large mosquito which appeared to be female was observed inside the room… semi-finished product storage area holding.
The room is located inside the unclassified but controlled environment corridor (Corridor-I) and is connected to room collection vails for visual inspection,” the drug regulator said in its report.
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 an audit,” the city-based drug maker had said.
Aurobindo officials were not immediately available for comment.
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 authorized personnel,” the FDA observed.
Equipment and utensils are not cleaned and maintained and sanitized 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.