FDA strengthening inspection of enterprises exporting food into the United States

In order to implement the US Food Safety Modernization Act (FSMA), the US Food and Drug Administration ("FDA") will double the number of foreign facility inspections each year. Accordingly, in 2012 and 2013, FDA conducted inspections of 1,200 and 2,400 foreign establishments respectively. It is expected that the number of inspections of foreign establishments to export food to the United States in the following years is as follows:


Year 2014 2015 2016
Number of inspection 4,800 9,600 19,200

Enterprises that are subject to inspection are mainly enterprises that produce and export products with high risks of food safety such as frozen seafood, canned food, etc. FDA will randomly choose a number of businesses to inspect, however, inspections can be conducted with neighboring businesses in the region where the FDA has chosen businesses to facilitate FDA business trips.

The inspection process is conducted starting with the FDA will send an email to the US representative of Vietnamese enterprises announcing the enterprise inspection schedule. Enterprises need to respond promptly to FDA notices because if within 5 days the business does not respond, FDA will increase the inspection of the sample of shipments of that enterprise exported to the United States, or suspend the posting code. Export of goods to the US by enterprises. The inspection schedule will be confirmed by both parties exactly before the time when the FDA goes to the enterprise for official inspection and inspection.

Regarding inspection costs, the company noted that businesses will not have to pay for the first inspection of the FDA. However, if the business does not meet the regulations and FDA requires some admenments to re-test, FDA will charge for re-inspections at a cost of US $224 per hour for those implementation in the US and US $325 per hour for work performed outside the US (in Vietnam, for example) applies to the fiscal year 2014 (October 1, 2014 to September 30, 2015) and changes through each year according to FDA notice at the end of each fiscal year. The charge will be applied to the time when FDA inspectors come to Vietnam to conduct facility inspections, from the time the inspector boarded the aircraft and to the enterprise's production facility, time prepare reports, time to evaluate production processes, time to analyze samples, etc.


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