For two years, the FDA has banned all of the drugs made at one of the Aurobindo Pharma antibiotics plants in Hyderabad, India, after inspectors found problems with contamination reporting. The India company now reports it is partially out of the woods with regulators.
Aurobindo told investors today that the FDA has removed the import ban on "nonsterile" products at its Unit VI cephalosporin facility, The Economic Times reports. That covers 9 products that had a value of about $33 million a year before the action. An FDA import alert list from yesterday indicates that the company's sterile products are still blocked, but the news was enough to push the company's shares up more than 8% on the Bombay Stock Exchange, The Wall Street Journal reports.
An FDA warning letter from 2011 for two plants in Hyderabad said during inspections of its Unit VI facility, the laboratory reported no contamination found on a microbial sample plate even though an inspector found a large colony of mold on it, which the laboratory manager confirmed. Later when the inspector asked to see the original plate again, he was told it had been destroyed. Inspectors noted other issues with monitoring.
At the company's Unit III plant, inspectors found bottles containing the wrong counts of tablets and some other issues, but that plant was not included in the import alert.
The company's problems have not been exclusively with the FDA. Last summer two of its plants were among a dozen that ran into issues with the state pollution control board for not meeting local standards.