The FDA has followed up a warning letter it issued to Pan Pharmaceuticals with an import alert that effectively extends a ban on the drugmaker's products in the U.S.
The regulatory agency posted the import alert, which directs that "detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices," on Dec. 8.
It is the latest action the regulatory agency has taken against Pan, which was also hit with a warning letter in 2012 for failing to register with the agency.
Pan, which is based in Gujarat, India, is only one of a long list of Indian drugmakers that the FDA has found to have substandard manufacturing processes. The FDA banned Pan's products in May and outlined why in a warning letter it posted in September.
During an inspection the FDA conducted last year, inspectors found that the plant was in disrepair, with holes and gaps that allowed both pigeons and other contaminants into manufacturing areas. Equipment was described as rusty and dirty with lubrication leaks. Insulation material around manufacturing lines was exposed.
The FDA has said that following other inspections that found the facility lacking, Pan--despite promising to improve--continued to make batches of drugs bound for the U.S. although repairs needed to conform to GMP standards were never made. When challenged by the agency, the company responded by saying it "decided to divert" those batches to the Indian market.
Indian drugmakers account for a large chunk of the generic and OTC medications 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. Forty-two Indian manufacturing facilities are currently banned from shipping products into the U.S., while 40 facilities in China are on the import ban list.
- check out the FDA Import Alert