Pharma companies exporting to the US should now rightly be on guard and start preparing for the inevitable “knock on the factory gate”.  the US Food and Drug Administration announced the expanded use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients. The release mentions that this change builds upon the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot programme in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.