Article 2. Inspection And Sampling of California Health And Safety Code >> Division 104. >> Part 5. >> Chapter 2. >> Article 2.
For purposes of enforcement of this part, any authorized
agent of the department may, upon presenting appropriate credentials
and at a reasonable time, do any of the following:
(a) Enter any factory, warehouse, or establishment in which any
food, drug, device, or cosmetic is manufactured, packed, or held;
enter any vehicle that is being used to transport or hold the food,
drug, device, or cosmetic; or enter any place where any food, drug,
device, or cosmetic is suspected of being held in violation of this
part.
(b) Inspect any factory, warehouse, establishment, vehicle, or
place, and all pertinent equipment, raw material, finished and
unfinished materials, containers, and labeling in the factory,
warehouse, establishment, vehicle, or place. In the case of any
factory, warehouse, establishment, or consulting laboratory in which
any food, drug, device, or cosmetic is manufactured, packed, or held,
inspection shall include any record, file, paper, process, control,
and facility that has a bearing on whether the food, drug, device, or
cosmetic is adulterated or misbranded, or falsely advertised within
the meaning of this part or whether it has been or is being
manufactured, packed, transported, sold, or offered for sale in
violation of this part.
The inspection authorized by Section 110140 shall not
include any of the following:
(a) Financial data.
(b) Sales data, other than shipment data.
(c) Pricing data.
(d) Personnel data, except data as to qualifications of technical
and professional personnel.
(e) Research data, except data relating to any new drug or
antibiotic drug that is subject to reporting and inspection under
this part or the federal act.
An authorized agent of the department may secure any sample
or specimen of any food, drug, device, or cosmetic. If the agent
obtains any samples prior to leaving the premises, he or she shall
leave a receipt describing any sample obtained.
An authorized agent of the department shall have access to
all records of carriers in commerce relating to the movement in
commerce of any food, drug, device, or cosmetic, or the holding of
that food, drug, device, or cosmetic during or after the movement,
and the quantity, shipper, and consignee of the food, drug, device,
or cosmetic. Evidence obtained under this section shall not be used
in a criminal prosecution of the person from whom it is obtained. The
carrier shall not be subject to the other provisions of this part by
reason of their receipt, carriage, holding, or delivery of any food,
drug, device, or cosmetic in the usual course of business as
carriers.
It is unlawful for any person to refuse to permit entry or
inspection, the taking of samples or other evidence, or access to
copying of any record as authorized by this part, or to conceal the
samples or evidence, or withhold evidence concerning them.
It is unlawful for any person to use to his or her own
advantage, or to reveal to any person other than to the director,
officers, employees, or authorized agents of this department, or to
the courts when relevant in any judicial proceeding under this part,
any information acquired under authority of this part concerning any
method or process which as a trade secret is entitled to protection.
However, the department may reveal trade secret information in
connection with the responsibilities of the department under this
part, to any employee of the federal Food and Drug Administration who
is authorized in writing by the Chief of the Food and Drug Branch of
the department or his or her designee to receive this type of
information. The employee receiving this type of information shall be
informed in writing of the prohibitions under this section, shall be
informed in writing that the information provided contains trade
secrets, as defined under state and federal law, and shall agree in
writing to keep the information confidential.