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US FDA finds 'female mosquito' in Aurobindo Pharma's unit during inspection

FDA also observed that Aurobindo Pharma employees lack the training required to perform their assigned functions

Press Trust of India  |  Hyderabad 

mosquito, aurobindo pharma, USFDA
Representative image | mosquito

officials found a 'large female mosquito' in a facility of 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 makers Unit 4 formulation facility nearhere last month

The audit was conducted between February 12-20.

"Building used in the manufacturing, processing, packing or holding of 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, 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.

Aurobindo officials were not immediately available for comment.

The FDA also observed that employees engaged in the manufacture,process, packing and holding of 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 is 'not of appropriate' design to facilitate operations for its intended design, the FDA said in the report.

First Published: Sun, March 11 2018. 18:53 IST