It is one thing if customers complain about finding impurities in an API from a supplier, but customers of India’s Polydrug Laboratories found a lot more than that. One reported particles and hairs, while another found an insect and dirt. But then there was the scoop that one customer reported, while in another API, there were goggles. And the FDA says Polydrug never bothered to check out any of these problems.
The uninvestigated complaints are lined out in a warning letter the FDA recently sent to the Indian drugmaker about its plant in Maharashtra, India, and which it posted to its website last week. In the warning the FDA noted that its investigator found a torn record in a warehouse that outlined 17 complaints of this nature, only two of which were listed in its official reports. It doesn’t matter that not all of those complaints were from U.S. customers, the FDA said. The drugmaker uses the same equipment and processes for its U.S. production and the fact that there were uninvestigated complaints about “APIs that were either sub-potent or contained filth” were more than enough indication for the agency that Polydrug has serious problems.
There were also big issues with data integrity, a common problem with Indian API makers. For example, a manager demonstrated for the investigator how results on an already finalized clinical outcomes assessment could be manipulated after it had been evaluated by the quality unit, the warning letter said.
Among the responses the FDA expects before it will allow Polydrug to sell any more APIs in the U.S. is a summary of investigations into all complaints the company has received since 2012 to determine the root cause of the problem and how it plans to address them.
The difficulties for Polydrug have been building for a year. In June 2015, European regulators banned products from three of its plants because the drug manufacturer was ignoring customer complaints. Health Canada followed suit a couple of weeks later, and then in September the FDA banned products from the Polydrug plant in Maharashtra.
- read the warning letter
India's Polydrug Labs criticized for contaminated APIs