FDA Indicates It Will Be Tightening Up Oversight of Overseas Manufacturers

The FDA has issued warning letters to eight overseas companies for importing drugs into the U.S. without registering their production facilities.  The United States Government Accountability Office (GAO) previously criticized the FDA for not properly overseeing overseas facilities.  The warning letters went to the following companies:

China-based Zhejiang Xianju Chemical Pharmaceutical Factory-- to read warning letter click here;
Chinese Peptide Company-- to read warning letter click here; to read close out letter click here;
India-based Sal Pharma-- to read warning letter click here; to read close out letter click here;
India-based Pan Drugs--to read warning letter click here;
Colombia-based CI Famacapsulas--to read warning letter click here;
Hong Kong-based Peking Medicine Manufactory--to read warning letter click here;
South Korea-based Korea Pharma Company--to read warning letter click here;
France-based Orlane--to read warning letter click here; to read close out letter click here;

The FDA had already warned each company of the need to register but the companies had failed to do so. The warning letters state:

Our records indicate that you have not registered  your establishment within 2011 or 2012, but have continued to manufacture, prepare, propagate, compound, or process drugs that were being imported or offered for import into the US. 

The warning letter also indicates that customs may refuse imports of these companies drugs until the companies register their facilities online.