The FDA posted another warning letter to Pan Pharmaceuticals that further extends an import alert issued last year, effectively keeping in place a ban on the drugmaker’s products in the U.S.
In the latest warning letter to Pan issued Aug. 25, 2016, the regulatory agency reiterated its concerns with the drugmaker’s Vadodara facility that were uncovered during an inspection in Nov.-Dec. 2015, as well as with the company’s response to previous warnings.
Pan was slapped with a warning letter about conditions at the plant last year and prior to that in 2012 for failing to register with the agency.
Pan, which is based in Gujarat, India, appears to be climbing to the top of a long list of Indian drugmakers the FDA has found to have substandard manufacturing processes.
Inspectors touring the site late last year cited Pan for disrepair, including rusty production equipment, contaminants near the manufacturing area, including mold, and building infrastructure that allowed pigeons and lizards into the production area.
FDA inspectors also found rodent droppings within three feet of bags said to contain drug product. When confronted by inspectors about the conditions, a Pan spokesman “told our investigator that your firm had no cleaning procedure for the equipment or facility,” the FDA said in the warning letter.
The agency also came down hard on Pan for its poor record-keeping and quality-control systems at the facility.
Indian drugmakers account for a large portion 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. In a survey by Reuters last year, 42 Indian manufacturing facilities were banned from shipping products into the U.S., while 40 facilities in China were on the import ban list.
- here’s the latest FDA warning letter