FDA hammers yet another Aurobindo plant for flawed data integrity

The FDA continues to hammer on Aurobindo's manufacturing failures, having issued its 10th Form 483 to the company in three years. (PIxabay)

FDA inspectors continue to chew up Aurobindo Pharma, finding more failures that raise questions about the quality of drugs produced by the Indian drugmaker. Just weeks after a stinging report was delivered to the drugmaker’s sterile drug plant in Telangana, the agency has blasted a finished drug facility there.

The inspection last month found failures that ran the gamut from data integrity failures at the plant to buckets containing air conditioner condenser water sitting in laboratories.

As with the sterile plant, a key finding is that the quality control unit at the plant is not doing its job to make sure drugs are unaffected by “objectionable conditions,” the FDA noted in the 15-page, 10-observation Form 483.

RELATED: Manufacturing problems persist for Aurobindo, U.S.' second-largest generics producer

The inspector found “Data reports in uncontrolled, loose handwritten notebooks” and unsigned reports about sterile operations. The plant’s investigations into data discrepancies didn’t often get to the root cause. The report said that out of 112 cases during a 16-month period, in 39 (nearly 35%) data were missing or incomplete.

Computers were not secure and cleaning protocols were not being followed, the report says. And then there were those four buckets half-full of air conditioner condenser water sitting in laboratories with no indication that they were being emptied regularly.

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This drip, drip, drip of regulatory actions appears to correspond to Aurobindo’s growing significance to the U.S. market. The company, which has more than 25 manufacturing plants globally, claims to have become the second-largest generics producer for the U.S. in numbers of prescriptions after it laid out $1 billion to buy the dermatology line of Novartis’ Sandoz in the U.S. It picked up three plants in that deal. This year, it got a manufacturing asset and seven branded oncology injectable products from Nevada-based Spectrum Pharmaceuticals in a $300 million deal.

As it has grown, so have the regulatory actions. It has been slapped with 10 Form 483s in the last three years. In addition to the Telangana plant problems, the FDA has cited an Aurobindo sterile injectables plant in Pashamylaram, Hyderabad. Return visits have sometimes found that problems persist at the same facilities. It also is among a number of drugmakers, including Teva Pharmaceutical and Mylan, that have had to recall drugs because suspected carcinogenic impurities were found in losartan or valsartan.