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Update – January 23, 2009
Guidance Document – Good Importer Practices (for comment)
The US Food and Drug Administration (FDA) has issued a new guidance
documents pertaining to responsibilities of importers in assuring the
safety of imported-FDA regulated products.
The first draft guidance document entitled Good Importer
Practices is designed to “prevent or detect potential problems
at critical points along the product’s life cycle to avoid placing the
US consumer at risk”.
The draft guidance contains the guiding principles indicating that
importers should develop a safety management program with defined job
functions, responsibilities and accountability to make sure imported
products are in line with FDA regulations.
For example, importers should know the foreign firms that produce the
products they purchase, any other firms with which they do business and
through which such products pass (e.g., consolidators, trading companies
and distributors). Importers should also understand the products that
they import and the risks associated with these products and ensure
proper control and monitoring of these hazards.
This guidance document is asking for comments that should be in by April
12, 2009.
The guidance is available for review at
http://www.fda.gov/oc/guidance/goodimportpractice.html
If you have any questions on this document of what it could mean to your
importing business please contact us at:
info@mdiconsultants.com and reference “GIPs”.
For more information on this please contact mdi at
info@mdiconsultants.com.
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