Aurobindo Pharma sinks 5% on USFDA observations
ETMarkets.com|
Mar 05, 2018, 11.05 AM IST
NEW DELHI: Aurobindo Pharma tumbled as much as 5 per cent on Monday amid media reports suggesting that the US drug regulator has issued Form 483 with nine observations to the drug maker's Hyderabad unit, citing deficiencies in maintaining manufacturing standards.
Among the nine observations cited were lack of employees trading, poor quality control criteria, deficient procedure for cleaning and maintenance of equipment, among others.
The stock fell 5.46 per cent to Rs 590 on the BSE.
The FDA representatives had inspected the facility on February 12-20.
"Equipment and utensils are not cleaned, maintained and sanitised at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product," the media reports quoted inspection team members as saying.
Among the nine observations cited were lack of employees trading, poor quality control criteria, deficient procedure for cleaning and maintenance of equipment, among others.
The stock fell 5.46 per cent to Rs 590 on the BSE.
The FDA representatives had inspected the facility on February 12-20.
"Equipment and utensils are not cleaned, maintained and sanitised at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product," the media reports quoted inspection team members as saying.
