Current through all regulations passed and filed through December 16, 2024
(A)
The submission of
an application that results in the issuance of a provisional license or
certificate of operation for a processor irrevocably gives the department
consent to conduct all inspections necessary to ensure compliance with the
processor's application, state law, Chapter 3796. of the Revised Code and the
rules promulgated in accordance with Chapter 3796. of the Revised Code. The
department may conduct the inspection independently, or may work with other
departments, state agencies, or local authorities, including the department of
agriculture, the division of industrial compliance and the state fire marshal,
to ensure compliance with the processor's application, state law, Chapter 3796.
of the Revised Code and the rules promulgated in accordance with Chapter 3796.
of the Revised Code.
(B)
An inspector conducting an inspection pursuant to this
section rule shall be accompanied by a type 1 key employee during the
inspection. The inspector may:
(1)
Review and make copies of all records maintained in
accordance with rule
3796:3-2-08
of the Administrative Code;
(2)
Enter any room in
the facility;
(3)
Inspect facility vehicles;
(4)
Review the
policies and procedures of the processor, including methods of
operating;
(5)
Survey the premises and any off-site
facilities;
(6)
Inspect all equipment, instruments, tools, materials,
machinery, or any other resource used to process medical marijuana and
manufacture medical marijuana products;
(7)
Request access to
locked areas in the facility;
(8)
Question licensed
employees at the location; and
(9)
Obtain samples
for testing of any medical marijuana products processed at the facility,
chemicals and ingredients used in processing medical marijuana, any labels or
containers for medical marijuana, or any raw packaged medical
marijuana.
(C)
A pre-approval inspection of a processor that is
required before the department issues a certificate of operation to a processor
possessing a provisional license under rule 3796:3-1-06 shalloccurata mutually
agreeable time. The department shall rely on the facility's application,
Chapter 3796. of the Revised Code and the rules promulgated in accordance with
Chapter 3796. of the Revised Code to facilitate the inspection and ensure
compliance of the facility. Upon the completion of the pre-approval inspection,
the department may issue:
(1)
A certificate of operation in accordance with rule
3796:3-1-06
of the Administrative Code, at which point the facility will be permitted to
begin operations; or
(2)
A written statement listing the deficiencies identified
during the inspection that must be remedied before a certificate of operation
will be issued by the department.
(a)
Upon receipt a statement of deficiencies, the processor
shall develop a plan of correction for each deficiency and submit the plan in
writing to the department for approval within ten business days after receipt
of the statement of deficiencies, unless a written extension is issued by the
department.
(b)
The plan of correction must include specific
requirements for corrective action that will be performed within thirty
calendar days after the department's acceptance of the plan of correction, or
the remaining time period under paragraph (B) of rule
3796:3-1-06
of the Administrative Code, whichever is greater.
(c)
If the plan of
correction submitted is not acceptable to the department or would prevent the
facility from obtaining a certificate of operation in accordance with rule
3796:3-1-06
of the Administrative Code, the department may either direct the medical
marijuana licensee to resubmit a plan of correction or the department may
develop a directed plan of correction with which the processor must comply.
Upon acceptance of the written plan of correction, the department and the
processor will sign a mutually binding agreement defining the terms under which
the processor will be issued a certificate of operation. If the parties are
unable to come to terms on the written plan of correction, the department may
take any action permitted under rule
3796:5-6-01
of the Administrative Code.
(d)
The department
shall re-inspect a processor upon the completion of the written plan of
correction. If the corrective measures meet the department's satisfaction, the
department shall issue a certificate of operation. If the corrective measures
do not meet the requirements of the written plan of correction, the department
shall take action in accordance with rule
3796:5-6-01
of the Administrative Code.
(D)
The department
may, at any time it determines an inspection is needed, with or without notice,
conduct an inspection of a processor to ensure compliance with the facility's
application, state law, Chapter 3796. of the Revised Code and the rules
promulgated in accordance with paragraph (A) of this rule. An inspection of a
processor may include, without limitation, investigation of standards for
safety from fire on behalf of the department by the local fire protection
agency. If a local fire protection agency is not available, the state fire
marshal may conduct the inspection after the medical marijuana processor pays
the appropriate fee to the state fire marshal for such
inspection.
(E)
Following an inspection conducted pursuant to paragraph
(D) of this rule, the department shall issue an inspection report that
documents the following:
(1)
The observations and findings of the
inspection;
(2)
The outcome of the inspection;
(3)
Any suggestions
for the processor to take into consideration; and
(4)
If applicable, a
written statement listing the deficiencies identified during the
inspection.
(a)
Upon receipt of a statement of deficiencies, the processor
shall develop a plan of correction for each deficiency and submit the plan to
the department for approval within ten business days after receipt of the
statement of deficiencies, unless a written extension is issued by the
department.
(b)
The plan of correction must include specific
requirements for corrective action that will be performed within thirty
calendar days. If the plan of correction submitted is not acceptable to the
department, the department may either direct the processor to resubmit a plan
of correction or the department may develop a directed plan of correction with
which the processor must comply. Upon acceptance of the written plan of
correction, the department and the processor will sign a mutually binding
agreement defining the terms agreed upon by the parties. If the parties are
unable to come to terms on the written plan of correction, the department may
take any action permitted under rule
3796:5-6-01
of the Administrative Code.
(c)
The department
shall re-inspect a processor upon the completion of the written plan of
correction. If the corrective measures meet the department's satisfaction, the
department shall indicate such on the inspection report and conclude the
inspection. If the corrective measures do not meet the requirements of the
written plan of correction, the department shall take action in accordance with
rule
3796:5-6-01
of the Administrative Code.
(F)
If an inspector
finds evidence of operational failures or conditions that create a likelihood
of diversion, contamination, risk to public health, or the occurrence of a
prohibited activities under rule 3796:5-6-02 of the Administrative Code, the
department may take immediate action authorized under rule
3796:5-6-01
of the Administrative Code.
(G)
To prevent
destruction of evidence, diversion or other threats to public safety, the
department may order an administrative hold of medical marijuana or medical
marijuana product or any books and records of any licensee. The department may
assess the costs of an investigation, including travel and the time of any and
all employees, to a licensee.