Utah Admin. Code R70-580-4 - Establishment Registration
(1) Pursuant to
Subsection 4-45-104(5), a
kratom processor shall register as a food establishment under Section
4-5-301.
(2) A kratom processor may be registered in
another state that meets or exceeds the requirements in Section 4-5-301 if they
provide the department with a copy of the registration from the federal or
state regulatory agency.
(3) A
kratom processor shall be subject to any statutes, rules, regulations,
policies, and procedures for food establishments specific to the form of the
kratom product offered for sale.
(4) In their application for registration,
each kratom processor shall identify any DBAs they operate that involve the
production of kratom products and the person that is legally responsible to
produce the kratom product. If the legally responsible person changes, the
department shall be notified of the change within 30 days.
(5) The application for registration shall
include a certification that the products manufacturer maintains a
manufacturing batch record (MBR) that documents:
(a) batch-to-batch uniformity;
(b) that each batch conforms to kratom raw
material specifications;
(c) that
each batch record shows that each step of the MBR was performed;
(d) that the production processes, controls,
and tests ensure reliable, reproducible results; and
(e) that the finished kratom product meets
each specification before the product is released for distribution.
(5) MBR testing shall be performed
on finished kratom products as identified by lot or batch number.
(6) Each MBR shall also include the following
information:
(a) the lot or batch
identification number of the tested product;
(b) the date received;
(c) the date of testing completion;
(d) the method of analysis for each test
conducted;
(e) a photo of the
kratom product that was tested;
(f)
the name and address of the kratom processor that manufactured the product;
and
(g) the name and address where
the MBR records are maintained and available for inspection by the
department.
Notes
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