The US Food and Drug Administration has raised procedural and cleanliness issues in Aurobindo Pharma subsidiary Eugia Pharma SEZ unit in Telangana, according to CNBC-TV 18.
Shares of Aurobindo Pharma reacted to the development, trading down nearly 2 percent to Rs 993.85, at 12.30pm on the NSE on March 15.
Aurobindo Pharma subsidiary's Telangana plant was slapped with seven observations in its Form 483 after inspection of the unit during February 19 to 29. The US drug regulator noted that procedures to prevent contamination were not followed and written records were not maintained leading to unexplained discrepancy.
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The US FDA also found that equipment were not suitably located to facilitate operations. It added that employees engaged in manufacturing and processing the drug product lack training. The plant did not have procedures to validate performance of manufacturing process and drugs.
On February 29, the company had restarted production in its terminally sterilised product lines at its Unit-III that was temporarily stopped to address some of the observations of the US FDA in their recent inspection.
Shortly, it restarted its aseptic lines too. “We also expect to start commercial production from the aseptic lines of the said facility in a phased manner beginning next week and to re-start all the lines by April 15, 2024,” the pharma company had informed the exchanges on March 12.
Aurobindo says that it produced more than 40 billion dosage forms in fiscal year 2023.
Also Read | Aurobindo Pharma restarts aseptic product distribution; shares trade higher
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