Pharma Whistle Blower Blog

“Real Breaking News!” India’s leading cGMP offender has now imported their deviant behaviors to its sterile products USA facility! Wochardt has been the subject of huge recalls and import bans by FDA over non-compliance of cGMPs, and now the FDA is apparently quite upset that...

The US FDA has finally released the long-awaited 483 Warning Letter for the incredible cGMP violations found in a January-February 2015 inspection at Emcure’s Hinjawadi plant in Pune, Maharashtra India. The plant was quickly banned by FDA in March 2015 from importing any drugs into the USA....

Rarely do we express disappointment with the FDA. They do an extraordinary job keeping us safe. We never waivered in our support for the FDA in 2007 when Congress (and the public) blamed the agency for the deaths of 149 Americans who received adulterated heparin.
Americans receive billions of...