India’s Aurobindo, which has been racking up FDA actions right and left, acknowledged Monday a recent agency inspection resulted in a Form 483.
The drugmaker, in a public filing Monday, admitted (PDF) its Unit 7 was issued the citation with seven observations following an inspection last month. The company provided no details but noted none of the observations are related to data integrity and it believes it can quickly deal with the issues raised.
But Aurobindo already has a lot of manufacturing improvements that it is making at other plants. The FDA uncovered issues with data integrity this year at two Aurobindo plants in Telangana, a sterile drug plant and a finished dose plant.
A few weeks later, the FDA issued a warning letter to Aurobindo’s plant in the Srikakulam district for issues the FDA said contributed to its valsartan products being tainted with N-nitrosodiethylamine, a suspected carcinogen that was detected in blood pressure meds last year. The inspection of the plant in February came just weeks after Aurobindo recalled 80 lots of valsartan.
Aurobindo placed the blame for the problem on ingredients it bought from a contractor and poor cleaning procedures. The FDA criticized the company for failing to get to the root cause of the issue. It also said Aurobindo did not initially let the FDA know about some changes in its processes that may have contributed to the presence of the impurities it uncovered.