Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-1 - REGULATIONS FOR DRUGS, DEVICES AND COSMETICS › Section 61N-1.019 - Inspections, Investigations, Monitoring

Current through Reg. 50, No. 138; July 16, 2024
(1) An inspection or investigation is a
				review or examination of an establishment permitted under the provisions of
				chapter 499, F.S., or any rule adopted thereunder, or of a non-permitted
				establishment for the purpose of protecting public health from misbranded or
				adulterated drugs, devices, or cosmetics or from any other violation of
				chapters 499 and 893, F.S., or any rules adopted thereunder. An inspection may
				also take place in a non-permitted establishment to assess whether the
				establishment complies with the requirements for a chapter 499, F.S.,
				permit.
(2) The department may
				inspect, monitor, and investigate all drug, device and cosmetic manufacturers,
				wholesalers, repackagers, distributors, or other establishments where drugs,
				devices or cosmetics are made, stored, sold, offered for sale, exposed for
				sale, or kept for sale or use, for the purpose of determining compliance with
				the provisions of chapters 499 and 893, F.S., or any rules adopted thereunder
				and to secure evidence of any non-compliance.
(3) Inspections and investigations may be
				announced or unannounced, at the discretion of the department. The owner,
				officer, or employee of the establishment shall make the premises and all
				records and other information required by chapters 499 and 893, F.S., or any
				rules adopted thereunder available to the department inspector.
(4) Inspections and investigations under this
				rule may include:
(a) Review and copying of
				all records pertaining to the manufacture, advertisement, storage, holding, and
				distribution of any prescription, over-the-counter or investigational drug,
				device or cosmetic. These records include, but are not limited to receiving
				documents, shipping documents, purchase orders, purchase requisitions,
				invoices, paid receipts, contracts, checks, deposits, and credits or debits in
				any form whatsoever;
(b) Entry to
				any establishment, vehicle or space therein in which drugs, devices, or
				cosmetics are manufactured, processed, repackaged, sold, brokered, held or
				transported;
(c) Entry to any
				establishment, vehicle, or space therein in which records related to drugs,
				devices, or cosmetics are held;
(d)
				Surveillance of procedures related to drugs, devices or cosmetics;
(e) Collection of facts and information
				related to drugs, devices or cosmetics;
(f) Questioning of persons who may have
				information relating to the inspection or investigation and taking sworn
				statements from these persons, all related to drugs, devices or
				cosmetics;
(g) Sampling any drug,
				device or cosmetic, including any related product (whether or not in finished
				form), material, component, document, literature, label, labeling or other
				evidence;
(h) Photographing any
				drug, device or cosmetic including any related component, materials, physical
				plant, storage condition, article or product;
(i) Observations and identification of:
1. Any drug, device or cosmetic consisting
				wholly or in part of filthy, putrid or decomposed substances,
2. Any undesirable conditions or practices
				bearing on filth, contamination, or decomposition which may result in a drug,
				device or cosmetic becoming adulterated or misbranded,
3. Any unsanitary conditions or practices
				which may render a drug, device or cosmetic injurious to health,
4. Any faulty manufacturing, processing,
				packaging, or holding of drugs, devices or cosmetics as related to current good
				manufacturing practices (CGMP) including recordkeeping,
5. Any deviation from recommended processing,
				storage or temperature requirements for any drug, device or cosmetic as
				specified by federal or state law,
6. Any deviation from FDA requirements for
				the label and labeling of any drug, device or cosmetic,
7. Any other action to determine compliance
				with chapters 499 and 893, F.S., and this rule chapter.
(j) Taking of evidence related to a drug,
				device or cosmetic that is or may be in violation of chapter 499 or 893, F.S.,
				or any rules adopted thereunder; and,
(k) Securing the removal of any potentially
				misbranded or adulterated drug, device, or cosmetic from commerce or public
				access.