Florida Regulations 61N-1.019: Inspections, Investigations, Monitoring
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(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.
(5) The department shall take reasonable steps to assure that a sampled product is not reintroduced into commerce if it is or has become adulterated or misbranded.
Rulemaking Authority 499.05, FS. Law Implemented 499.051, 499.052, 499.065 FS. History-New 7-8-84, Formerly 10D-45.545, Amended 11-26-86, 7-1-96, Formerly 10D-45.0545, Amended 4-17-01, Formerly 64F-12.019.
Terms Used In Florida Regulations 61N-1.019
- Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
(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.
(5) The department shall take reasonable steps to assure that a sampled product is not reintroduced into commerce if it is or has become adulterated or misbranded.
Rulemaking Authority 499.05, FS. Law Implemented 499.051, 499.052, 499.065 FS. History-New 7-8-84, Formerly 10D-45.545, Amended 11-26-86, 7-1-96, Formerly 10D-45.0545, Amended 4-17-01, Formerly 64F-12.019.