FDA castigates Indian drugmaker over mess at API plant

If the holes in the ceiling and walls allowing pigeons to fly around manufacturing equipment at India's Pan Drugs were not enough to warrant an FDA warning letter, then the fact that it also was not thoroughly testing its APIs did the trick.

The Gujarat, India, company became another on the long list of Indian drugmakers that have left the FDA unimpressed with their manufacturing standards. The FDA banned the company's products in May and explained why in a warning letter posted this week. The drug company is a repeat offender, having received a 2012 warning letter for failing to register with the FDA.

During the most recent inspection last year, FDA inspectors said that the plant was in disrepair, with holes and gaps that not only allowed in the pigeons but also would allow other contaminants into manufacturing areas. Equipment was rusty and dirty and had lubrication leaks. There was exposed insulation material around manufacturing lines.

The FDA said Pan shut the plant down for repairs after the agency notified it it was coming in for an inspection in July 2014, but the agency said it has heard that before from Pan. The company claimed during a 2011 inspection that the plant was under renovation and promised to make repairs and maintain the facility.

The FDA said that Pan continued to make batches bound for the U.S. even after noting that repairs were needed to make the plant conform to GMP standards. When the FDA challenged Pan about those products, its response was "we have decided to divert the referred batches" to the Indian market.

Indian drugmakers account for a huge piece of the generic and OTC meds that U.S. consumers use, about 40%, but the Indian industry also accounts for many of the warning letters and plant bans that the FDA issues. When the FDA instigated an import alert last week against another Indian drugmaker, Polydrug Laboratories, Reuters checked records and said that 44 Indian manufacturing facilities are currently banned from shipping products into the U.S.

- here's the warning letter

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