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USFDA Warning letter to Aurobindo

02nd July 2019

Indian Drug maker, Aurobindo Pharma received a warning letter from the FDA about violations of good manufacturing practice (GMP) at one of the company’s facilities in Srikakulam District, Andhra Pradesh following a six-day inspection in February.

The warning letter received by the company was mainly about the nitrosamine impurities in angiotensin Ⅱ receptor blockers (ARBs). In the same issue, FDA was prompted to recall hundreds of lots of the drugs from multiple manufactures.

After FDA’s inspection, Aurobindo started its voluntary recall of ARB drugs along with 38 lots of Valsartan tablets because an N-nitrosodiethylamine (NDEA) impurity was present in them.

The European Directorate for the Quality of Medicines (EDQM) testing reports prior to January 2019 were also cited, which referred to the impurity found in one of the company’s products. EDQM suspended Aurobindo’s certificate of suitability (CEP) for irbesartan in October 2018 after identifying NDEA impurity.

In the warning letter, it was mentioned that Aurobindo failed to adequately investigate root cause of impurity. During inspection, FDA also observed rust on the equipment’s surface used in APIs manufacturing. The company also failed to submit a required supplemental report detailing changes for one of its drug master files.

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