homemarket Newsstocks NewsAurobindo Pharma API unit receives 7 observations from US FDA after inspection
Aurobindo Pharma API unit receives 7 observations from US FDA after inspection
The Aurobindo Pharma stock is under pressure falling almost 15 percent in the last five trading sessions. In the past month, the stock has tanked 28 percent.
The Aurobindo Pharma stock is under pressure falling almost 15 percent in the last five trading sessions. In the past month, the stock has tanked 28 percent.
The pharma major's API unit (Unit-1) was inspected by the US FDA (United States Food and Drug Administration) between August 2 and August 12 and seven key observations have been issued. CNBC-TV18 has accessed this Form 483.
US FDA's observations
The inspection by the US drug administrator has found that systems for evaluating and qualifying critical material suppliers are inadequate. Further, sampling plans for raw materials and intermediates are inadequate.
The inspection also found that components used in manufacturing are not tested and released prior to use and proposed changes are not adequately evaluated.
US FDA has also alleged that quality control failed to ensure investigations were scientifically sound. Also, quality-related activities have not been documented at the time of performance.
The last point raised is that the equipment at the API unit is not properly maintained.
Aurbindo Pharma already has an official action indicated (OAI) status. This increases the probability of sterner action.
With these seven observations, one needs to see what the next step would be by the company in terms of resolution of these observations and what the USFDA would do subsequently.
(Edited by : Abhishek Jha)
First Published: Aug 20, 2021 12:34 PM IST
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