The FDA spanked an Indian API maker last month in a warning letter for having pigeons flying around its facility, as well as not adequately testing its products. Today yet another API maker got written up for pest problems. This time, in addition to birds in the facility, a lizard was seen crawling around in a storage warehouse. Oh, and there were also problems with testing drugs.
Besides failing to have a pest control program, the warning letter to Unimark Remedies in Mumbai cited the drugmaker for a host of record-keeping issues that have come up commonly among inspections of Indian facilities. Records were not filled out when batches were being produced. There were records purportedly signed by employees on dates that they weren't even there. There were gaps in records for products returned "due to the presence of extraneous threads." There were no audit trails for some testing and no security on some equipment to make sure that failed test results were not deleted by employees, two issues it has cited a raft of other Indian drugmakers over, and so on.
Last month, a warning letter was sent to Pan Drugs for many of the same issues, including the fact that pigeons were seen flying around production equipment. In the case of Pan, the FDA also had issued an import alert, banning any further products from being allowed into the U.S. until problems were resolved.
But Pan and Unimark are part of a growing list of Indian drugmakers that have left the FDA unimpressed with their manufacturing standards. According to a recent survey by Reuters, 44 Indian manufacturing facilities are currently banned from shipping products into the U.S. That list includes some of India's largest drugmakers.
- here's the warning letter