Indian Company Pan Drugs Redoing API Program After FDA Warning Letter
September 16th, 2015 // 2:19 pm @ jmpickett
Pan Drugs in India got an FDA warning letter this week, with the federal agency citing the company for several GMP problems. The facility is located in Nadesari, Vadodara.
FDA stated that the company did not maintain, repair and keep its API manufacturing units clean. FDA noted that there were holes in the roof and walls, which allowed birds to get near some of the drug production equipment. There also were gaps and holes in the outside walls of the building where piping and air ducts came in.
The API manufacturer also did not maintain its API making equipment. The FDA inspector noted that there were lubrication leaks, rust, dirt and insulation that was exposed around the drug manufacturing machines.
FDA also noted in the warning letter that Pan Drugs was still manufacturing drugs and APIs for the Indian market, even after FDA noted that its production equipment had GMP flaws.
However, a Pan Drugs representative noted that the company had stopped manufacturing drugs after the FDA 483 was issued in July 2014.
The company told FDA that it was totally committed to ceasing all drug production until the facility was renovated. They noted that they are totally taking down the affected manufacturing areas and are rebuilding them.
The company representative also noted that the firm only exports a single API to the US market, which is guaifenesin which is used in OTC drugs. That was only in the amount of 25 tons each year.
