Current through Reg. 49, No. 38; September 20, 2024
(a) Inspection.
(1) To enforce these sections or the Texas
Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 (Act), the
Commissioner of the Department of State Health Services (commissioner), an
authorized agent, or a health authority may, on presenting appropriate
credentials to the owner, operator, or agent in charge of a place of business:
(A) enter at reasonable times a place of
business, including a factory or warehouse, in which a device is manufactured,
assembled, packed, or held for introduction into commerce or held after the
introduction;
(B) enter a vehicle
being used to transport or hold a device in commerce; or
(C) inspect at reasonable times, within
reasonable limits, and in a reasonable manner, the place of business or vehicle
and all equipment, finished and unfinished materials, containers, and labeling
of any item and obtain samples necessary for the enforcement of these sections
or the Act.
(2) The
inspection of a place of business, including a factory, warehouse, or
consulting laboratory, in which a restricted device is manufactured, assembled,
packed, or held for introduction into commerce extends to any place or thing,
including a record, file, paper, process, control, or facility, in order to
determine whether the device:
(A) is
adulterated or misbranded;
(B) may
not be manufactured, introduced into commerce, sold, or offered for sale under
the Act; or
(C) is otherwise in
violation of these sections or the Act.
(3) An inspection under paragraph (2) of this
subsection may not extend to:
(A) financial
data;
(B) sales data other than
shipment data;
(C) pricing
data;
(D) personnel data other than
data relating to the qualifications of technical and professional personnel
performing functions under the Act; or
(E) research data other than data:
(i) relating to devices; and
(ii) subject to reporting and inspection
under regulations issued under §519 or §520(g) of the Federal Food,
Drug, and Cosmetic Act, as amended.
(4) An inspection under paragraph (2) of this
subsection shall be started and completed with reasonable promptness.
(b) Receipt for samples. An
authorized agent or health authority who makes an inspection of a place of
business, including a factory or warehouse, and obtains a sample during or on
completion of the inspection and before leaving the place of business, shall
give to the owner, operator, or the owner's or operator's agent a receipt
describing the sample.
(c) Access
to records.
(1) A person who is required to
maintain records referenced in these sections or under the Texas Food, Drug,
and Cosmetic Act, Health and Safety Code, Chapter 431 (Act) or §519 or
§520(g) of the Federal Food, Drug, and Cosmetic Act or a person who is in
charge or custody of those records shall, at the request of an authorized agent
or health authority, permit the authorized agent or health authority at all
reasonable times access to and to copy and verify the records.
(2) A person who is subject to licensure
under these sections of this subchapter shall, at the request of an authorized
agent or health authority, permit the authorized agent or health authority at
all reasonable times access to and to copy and verify all records showing:
(A) the movement in commerce of any
device;
(B) the holding of any
device after movement in commerce; and
(C) the quantity, shipper, and consignee of
any device.
(d) Retention of records. Records required by
these sections of this subchapter shall be maintained at the place of business
or other location that is reasonably accessible for a period of at least 2
years following disposition of the device unless a greater period of time is
required by laws and regulations adopted in §
229.432
of this title (relating to Applicable Laws and Regulations).
(e) Adulterated and misbranded device. If the
Department of State Health Services (department) identifies an adulterated or
misbranded device, the department may impose the applicable provisions of
Subchapter C of the Act including, but not limited to: detention, emergency
order, recall, condemnation, destruction, injunction, civil penalties, criminal
penalties, and/or administrative penalties. Administrative and civil penalties
will be assessed using the Severity Levels contained in §
229.261
of this title (relating to Assessment of Administrative or Civil
Penalties).
