Registration & Agency
Every
owner, operator or agent-in-charge of either
a domestic or foreign facility engaged in the
manufacturing/processing, packing or holding
of food for consumption in the United States,
must register its facility with the FDA.
Just
prior to the implementation of the FDA legislation,
PBB Global Logistics released a letter detailing
the new regulations and our recommendations
regarding the necessary appointment of a U.S.
agent prior to registering.
PBB
will help any non-U.S. based company fulfill
their regulatory requirements by serving as
an experienced, full-service intermediary between
your company and the FDA. PBB can also handle
prior notice in addition to agency requirements
in order to provide a convenient, single point
of contact for all your FDA needs. Our highly
trained Customs and trade specialists will
resolve problems, advise on preventing or minimizing
penalty situations, keep you informed, consult
on all FDA issues including related requirements
and act as an emergency contact 7/24/365. In
addition, as a licensed Customs broker, PBB
can provide services to help maintain or increase
your access to U.S. markets and act as a single
point of contact for cross-border shipments,
ensuring a seamless, worry-free process from
start to finish.
As a
Customs broker, PBB is ideally positioned to
provide agency services to clients, helping
them maintain or increase their access to U.S.
markets. PBB offers a number of other benefits
including:
- A
single point of contact for cross-border
shipments.
- Efficiency:
PBB can handle the FDA's prior notice process,
since we are already privy to our client's
shipment details for Customs purposes.
- Effective
representation thanks to our history of working
with FDA.
- Up-to-date
information and insight on important topics
thanks to our association with governmental
and industry organizations.
What
services will PBB provide as an agent?
As an
agent, PBB can:
- Help
non-U.S. clients fulfill their regulatory
requirement to obtain a U.S. agent.
- Serve
as intermediary between the client and the
FDA.
- Advise
the client on any communication from the
FDA and related requirements. Help resolve
problems.
- Advise
on preventing (or minimizing) penalty situations.
- Act
as emergency contact which requires maintaining
a dedicated emergency contact number 24 hours
a day, 7 days a week.
- Accept
service of process from FDA on behalf of
clients.
- Maintain
documentary and communication records if
these are required.
Please
note that before filling out the registration
form, a U.S. agent must be appointed. If you
wish to appoint PBB as your U.S. agent for
FDA purposes, download and complete the Agency
Agreement and Appendix A.
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