A recent report says that FDA inspections of Indian drugmakers tripled between 2010 and 2015, and that trend continues this year, with the latest to feel the heat being Sal Pharma.
The FDA posted a warning letter on Tuesday for the Hyderabad API facility, saying it pawned off the products of unapproved API producers and claimed to its U.S. customers that they had been manufactured by Sal. Those included gastrointestinal API lansoprazole and itraconazole, an API used in antifungal drugs.
The company said it would stop shipping to the U.S. and not resume until it had fixed the problems, but the FDA still wants to know just how Sal intends to do that. The FDA placed Sal Pharma’s products on its import alert list in February.
The warning letter followed a late June, early July inspection of the facility during which inspectors discovered that Sal Pharma had generated certificates of analysis (COA) in which it removed the name of the original producer and replaced it with information from its own letterhead, the report said.
“Omitting information from COA compromises supply-chain accountability and traceability, and may put consumers at risk,” the FDA told the company.
The company acknowledged that someone would use a car and pick up APIs from various suppliers, relabel them and then take them to a clearing agent. The company acknowledged it didn’t know whether the clearing agent stored the APIs in a temperature-controlled environment.
The FDA has uncovered other companies faking COAs in recent months, including a couple of Chinese companies. In March, the FDA issued a warning letter to Lumis Global Pharmaceuticals of Wuhan after finding it generating fake COAs. That followed the posting of a warning letter in January that made the same charges against the Suzhou Pharmaceutical Technology facility in Suzhou, Jiangsu Province.