Inspections, Compliance, Enforcement, and Criminal Investigations
Inspection Project Area Listings
Project 03 - CFSAN – Food borne and Biological Hazards
Includes all field activities directed towards reducing the incidence of microbiological hazards, filth, decomposition and foreign objects in the nation's food supply. Included are all field activities covering the prevention of microbiological and sanitation problems through industry and consumer education together with research designed to identify new hazards and develop methods for their control.
Project 04 – CFSAN – Pesticides and Chemical Contaminants
Includes all field activities directed towards identifying and assessing health risks posed by chemical contaminants, such as industrial chemicals, pesticides, and heavy metals that may find their way into human foods.
Project 07 - CFSAN - Molecular Biology and Natural Toxins
Includes all field activities directed towards reducing food safety problems caused by aflatoxins and mycotoxins.
Project 09 – CFSAN – Food and Color Additive Petition Review & Policy Development
Includes all field activities directed towards assuring that all food activities added to human food and color additives added to cosmetics and human foods, directly or indirectly are safe. The project also includes Bioresearch (non-clinical laboratories) work done on food and color additive petitions.
Project 18 - CFSAN – Technical Assistance: Food and Cosmetics
Includes all field activities directed towards: assuring the acceptability of food handling and preparation practices at the retail level or where otherwise provided to consumers, such as institutional and public eating places, food stores, and food vending locations; construction and operation of food, water, wastes, and related systems and/or services in conjunction with or on board interstate conveyances (aircraft, buses, passenger railroad, and vessels); assuring that shellfish are safe for human consumption; and assuring that the nation’s milk supply is uniformly safe and wholesome by providing technical assistance and guidance to the states and other local governments.
Project 21 – CFSAN - Food Composition, Standards, Labeling and Economics
Includes all field activities directed towards assuring:
- That the nutritional quality of foods is maintained or improved in relation to fortification and that the labeling reflects the nutritional contents of the food when applicable which includes infant formula, medical foods, dietary supplements and the Nutritional Labeling and Education Act (NLEA).
- That the consumer is not economically harmed by misleading labeling or packaging.
- That product integrity is maintained through the development, promulgation, and enforcement of standards and regulations.
Project 29 – CFSAN - Colors and Cosmetics Technology
Includes all field activities directed towards assuring that all cosmetics are safe and adequately labeled.
Project 41 – CBER – Human Cellular, Tissue and Gene Therapies
Includes all field activities related to the regulation of biological therapeutic products, with the exception of certain therapeutic blood products. Biological therapeutics includes cytokines such as interferons, interleukins, and tumor necrosis factors; monoclonal antibodies; and hematological products, such as thrombolytic agents, and hematopoietic products, such as thrombolytic agents, and hematopoietic growth factors. NOTE: Most biological therapeutic products have been transferred to CDER.
Project 42 – CBER - Blood and Blood Products
Includes all field activities directed towards assuring that all blood and blood products and devices associated with their manufacture are safe, effective, and properly labeled. Also includes all field activities directed towards assuring that persons and establishments conducting biologics bio-research provide adequate evidence of product safety and efficacy and protect the rights of human subjects who participate in the studies.
Project 45 – CBER - Vaccines and Allergenic Products
Includes all field activities directed towards assuring that vaccines and allergenic products are safe, effective, and properly labeled. In addition to ensuring the safety, purity, potency and effectiveness of vaccines and allergenic products, this project has additional responsibilities mandated by the National Childhood Vaccine Injury Act.
Project 46 – CDER - New Drug Evaluation
Includes all field activities directed towards assuring that new human drugs are evaluated on the basis of adequate evidence of safety and efficacy; are properly labeled; and that clinical investigations of new human drugs are properly designed and safeguard the rights of human subjects.
Project 48 – CDER - Bioresearch Monitoring: Human Drugs
Includes all field activities directed towards assuring that non-clinical and clinical investigations are conducted in a scientific manner that will afford protection to human subjects participating in clinical trials and will produce valid bioresearch data. It also includes all activities directed toward assuring that the practices of drug abuse treatment programs comply with the established standards for registration and for treatment of narcotic addiction.
Project 52 – CDER - Generic Drug Evaluation
Includes all field activities directed towards assuring that all human drugs approved for marketing between 1938 and 1962 are properly labeled and have an approved ANDA or NDA and that drugs not meeting these criteria are removed from the market.
Project 53 – CDER - Postmarketing Surveillance and Epidemiology: Human Drugs
Includes all field activities directed towards actively monitoring the short and long term effects of marketed drugs, including their utilization, in order to detect potential safety problems and to establish a scientific basis for regulatory actions.
Project 56 – CDER - Drug Quality Assurance
Includes all field activities directed towards ascertaining the quality of human drugs by assuring that they manufacturing, processing, packing, and holding of drugs and the facilities and controls used in these processes meet the established specifications; that they are in compliance with current Good Manufacturing Practices Regulations; and, that these establishments register and submit drug listing information in accordance with the Drug Listing Act of 1972. Activities also include contributing to the development and improvement of compendial standards for human drug products to assure their adequacy as regulatory standards. NOTE: Includes most biological therapeutic products transferred from CBER.
Project 58 – CDER - Prescription Drug Advertising and Labeling
Includes all field activities directed towards assuring that prescription drug advertising is accurate and truthful and labels contain latest information for safe and effective use.
Project 61 – CDER - Over-the Counter Drug Evaluation
Includes all field activities directed towards developing standards for the safety and efficacy of all OTC human drugs, monitoring the implementation of these standards to assure proper formulation and labeling, and removing from market OTC human drugs which do not meet these criteria.
Project 63 – CDER - Health Fraud: Human Drugs
Includes all field activities (import and domestic) directed towards detecting, investigating and taking corrective action against fraudulent drug and biological products which present the public with direct and indirect hazards and major economic frauds. Educate consumers through publicity before their health or pocket books are adversely affected.
Project 68 – CVM - Pre-Approval Evaluation of Animal Drugs and Food Additives
Includes all field activities directed towards assuring that:
- New animal drugs and food additives are safe and effective and that they are properly compounded, formulated, and manufactured.
- Non-clinical and clinical investigations intended to demonstrate the safety or effectiveness or new animal drugs and food additives are conducted in a scientific manner. Bioresearch inspections do not require product coding on FDA-481A. FDA-481C (Products Covered) must be complete.
Project 71 – CVM - Monitoring of Marketed Animal Drugs, Feeds and Devices
Includes all field activities directed towards assuring that:
- Animal drugs, feeds and medical devices are: a.) Safe and effective; and b.) Not adulterated or misbranded.
- Medicated feeds are properly formulated, manufactured, labeled and distributed so that they are safe and effective for their intended use.
- Harmful residues from the improper use of these drugs or medicated feeds do not enter the human food supply.
Project 81 – CDRH - Post-Market Assurance: Devices
Includes all field activities directed towards assuring that medical and radiological device problems are detected early to protect the public from health hazards and to provide data complaints, significant problems and potential hazards so that corrective action can be initiated for hazardous products in the marketplace.
Project 82 – CDRH - Compliance: Devices
Includes all field activities directed towards assuring that medical and radiological devices are safe and effective through implementation of regulations, surveillance or firms and products, encouragement of voluntary compliance, and initiation of necessary actions.
Project 83 – CDRH - Product Evaluation: Devices
Includes all field activities directed towards classification of devices, review of pre-market notification [510 (k) s]/ pre-market approval applications for medical devices, review of requests for investigational device exemptions and evaluations of product development protocols.
Project 84 – CDRH - Science: Devices
Includes all field activities directed towards applied science, ongoing research efforts relating to the effects of long-term, low-level exposure to non-ionizing radiation, bioeffects of light radiation, RF and microwave radiation, and ultrasound exposure, as well as work on the mechanical and biotoxic properties of implantable material.
Project 85 – CDRH - Mammography Quality Standards Act (MQSA) Authority
Includes all field activities directed towards assuring that all certified mammography facilities are in compliance with the Mammography Quality Standards Act (MQSA). Inspects certified mammography facilities in accordance with specified procedures, conducts follow-up inspections of non-compliant establishments and performs on-site quality assurance audits of FDA and State MQSA inspectors to ensure their proficiency in conducting mammography facility inspections.
Project 86 – CDRH - Radiation Control and Health Safety Act (RCHSA) Authority
Includes all field activities directed towards assuring that radiological device problems are detected early to protect the public from health hazards and to provide data complaints, significant problems and potential hazards so that corrective action can be initiated for hazardous products in the marketplace.
Project 88 - ICA (Interagency Cooperative Activities)
Includes any FACTS/OASIS reportable field operations by any field personnel, performed in conjunction with interagency activities with any federal agency.
Project 99 – General
Includes those field operations which cannot, or should not, be identified as work performed in support of a specific Center’s Project related functions.
Project 96 – Tobacco
Includes all field activities directed towards setting performance standards, reviewing premarket applications for new and modified tobacco products, application of new warning labels and establishing and enforcing advertising and promotion restrictions of tobacco products and manufacturers.