Inspections, Compliance, Enforcement, and Criminal Investigations

SUBCHAPTER 1.10 - REFERENCES

Table of contents

This subchapter will help you to locate regulatory references and FDA staff.

1.10.1 - LAW, REGULATION AND GUIDANCE

The Food Safety Modernization Act (FSMA) of 2011, Family Smoking and Tobacco Control Act (Tobacco Control Act) of 2009, Food and Drug Administration Amendments Act of 2007 (FDAAA), the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the FDA Modernization Act of 1997, (FDAMA), the International Conference on Harmonization (ICH), Mutual Recognition Agreement (MRA), national emergencies and initiatives, and other forces continue to impact FDA inspectional operations as changes in law, regulation, guidance and internal procedures issue. As ICH members (Japan, U.S. and European Union) reach consensus agreements, ICH guidelines are adopted by all three governments. In the United States, they may replace outstanding FDA guidance in the medical device, human and animal drug areas. FSMA amended the FD&C Act to ensure the US food supply is safe by shifting the focus from response to prevention. The Tobacco Control Act amended the FD&C Act giving the agency the authority to regulate the manufacture, distribution, and marketing of tobacco products. Amendments under FDAAA include the addition of Section 417 to the FD&C Act authorizing the establishment of a Reportable Food Registry (RFR) – an electronic portal for industry to report when there is reasonable probability that an article of food will cause serious adverse health consequences. Unless exempted, the Bioterrorism Act and implementing regulations require most domestic food facilities and foreign food facilities who export to the U.S. to register as of December 12, 2003; FDA began accepting registrations on October 16, 2003. The Bioterrorism Act requires that FDA receive prior notice of food imported into the United States, beginning on December 12, 2003. The 2002 MDUFMA authorizes FDA to charge user fees for medical device premarket review; it allows third party medical device inspections, sets out new regulatory requirements for single-use devices, and directs FDA to establish the Office of Combination Products. FDA drug GMP initiative and Process Analytical Technology (PAT) efforts are underway.

In conducting inspections and investigations according to changing policies, in order to be effective, FDA regulators must understand the difference between regulatory requirements and guidance.

Laws or statutes, enacted by Congress, and regulations or rules, promulgated by Federal agencies, contain regulatory requirements.

FDA's guidance documents, on the other hand, have a different legal status and serve purposes different from laws and regulations. The purposes of guidance documents are to:

  1. Provide assistance to the regulated industry by clarifying requirements that have been imposed by Congress or issued in regulations by FDA, and by explaining how industry may comply with those statutory and regulatory requirements, and
  2. Provide specific review and enforcement approaches to help ensure that FDA's employees implement the agency's mandate in an effective, fair, and consistent manner.

The term "guidance documents" includes documents prepared for FDA staff, applicants/sponsors, and the public that:

  1. Relate to the processing, content, and evaluation/ approval of submissions;
  2. Relate to the design, production, manufacturing, and testing of regulated products;
  3. Describe the agency's policy and regulatory approach to an issue; or
  4. Establish inspection and enforcement policies and procedures.

Guidance documents do not include documents relating to internal FDA procedures, agency reports, general information documents provided to consumers, speeches, journal articles and editorials, media interviews, press materials, warning letters, or other communications directed to individual persons or firms. FDA procedures issued for staff to follow, such as the IOM, are internal procedures intended to direct your activities and you are to follow them.

Guidance documents for industry do not establish legally enforceable rights or responsibilities and are not legally binding on the public or the agency. Rather, they explain how the agency believes the statutes and regulations apply to certain regulated activities. For a more detailed explanation of the background to the development, issuance and use of guidance documents see the preamble to the February 27, 1997 Federal Register Volume 62 Number 39. To access 21 CFR 10.115 Good Guidance Practices, see http://edocket.access.gpo.gov/cfr_2001/aprqtr/pdf/21cfr10.115.pdf . Also see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070804.htm to access the CDRH Manual for the Good Guidance Practices (GGP) Regulation - Final Guidance for FDA Staff (2/01). For a comprehensive list of FDA current guidance documents, see http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/Guidanceforindustry/default.htm.

The Federal Register is the official daily publication for rules, proposed rules, and Notices of federal agencies and organizations as well as Executive Orders and other Presidential documents. The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive Departments and agencies of the Federal Government. Most regulations enforced by FDA are located in Title 21 of the CFR. For a listing of all titles in the U.S Code, see http://www.law.cornell.edu/uscode/#TITLESdisclaimer icon.

1.10.2 - SOURCES OF INFORMATION

1.10.2.1 - Investigator Training and Certification

ORA's Investigator certification program provides a focused training plan for the ongoing professional development of agency investigators. The program is designed to address the specific needs of agency District Offices by providing a structured mechanism for investigators to maintain the required levels of competency.

Performance certification promotes uniformity in investigator training and experience. The program is designed to promote the efficient use of (ORA) training resources. Investigators who complete the program will be formally recognized as meeting the competencies required at the specific certification level achieved.

Additional information on ORA's Investigator Certification program, including procedure documents and forms for certification in specific commodity areas, is available on ORAU on the Division of Human Resource Development’s (DHRD) intranet site.

In addition to managing the investigator certification program through ORAU, DHRD (HFC-60) manages and coordinates with Regions and Districts, the ORA staff's overall ongoing professional development training through in person and web-based courses, broadcasts, and video conferences. For more information on available training on the ORAU, see DHRD’s intranet site.

1.10.2.2 - Contacting FDA Employees

Easily finding colleagues you need to contact can make your work life more productive. See IOM 1.8 and 1.9 for the organization of FDA offices, including a directory of ORA field offices and program managers. The Office of Regulatory Affairs organizational directory (blue pages) is available in electronic format. See ORA Directory. At the end of the blue pages, find a listing of District program monitors. For FDA Center staff directories:

CFSAN - See http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm135675.htm

CBER - See http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm135943.htm

CDRH - See http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm135673.htm. For a list of resource staff by topic of specialization in the Division of Small Manufacturers, Consumer and International Affairs, see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ucm142656.htm

CVM - See http://www.fda.gov/downloads/AboutFDA/CentersOffices/CVM/UCM143846.xls

CDER - See http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm135674.htm. For a list of resource staff, by topic of speciali­zation, in the CDER Office of Manufacturing and Product Quality, (HFD-320) see http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm096102.htm.

CTP - See http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/AbouttheCenterforTobaccoProducts/default.htm

To obtain contact information for an FDA employee in your e-mail directory, find the name, and then click on "properties" for telephone number and office designation. If the telephone number listed is inaccurate for an FDA employee you wish to contact, call the FDA Personnel Locator at telephone number 301-443-1544 for an update.

You may also search the Department of Health and Human Services electronic employee directory, which includes FDA and all other HHS staff. See http://directory.psc.gov/employee.htm. See IOM Chapter 3 for other Federal agency and State contact information, or to check the Directory of State and Local Officials on the FDA web site, see http://dslo.afdo.org/disclaimer icon.

1.10.2.3 - Internet and Intranet

The FDA Internet Web site at http://www.fda.gov provides access to FDA references in electronic format: laws, regulations, policy, guidance, correspondence, reports and other publications. From the FDA home page link to laws enforced by FDA and related statutes at www.fda.gov/opacom/laws. From there you can access the Code of Federal Regulations, the Federal Register, and FDA Manuals and Publications. Under the heading "FDA Manuals and Publications" is a link to a comprehensive list of current FDA guidance documents at http://www.fda.gov/opacom/morechoices/industry/guidedc.htm.

Two features will facilitate your navigation of the FDA website, For the FDA "Website Index", see www.fda.gov/opacom/hpchoice.html. To access the FDA "Website Map", see http://www.fda.gov/SiteMap/default.htm.

Subscribe to various FDA e-mail lists for updates on web postings. See www.fda.gov/emaillist.html.

FDA libraries are accessible on the FDA intranet site.

1.10.2.4 - FDA on Disk

The FDA Gold Disk is an electronic source of regulatory references maintained on CD-ROM by the Office of Policy and Risk Management (OPRM). To order a Gold Disk, contact San Francisco District, Gwen Wong, 510-337-6890. FDA personnel who do not have access to an FDA network server can use the Gold Disk in an off-line mode. It may also be available on your local district server. Check with your computer support personnel. The FDA gold disk is a convenient source of FDA regulatory references in electronic format when Internet access is not available. It contains, for example, the Federal Food Drug and Cosmetic Act, Title 21 CFR, Compliance Policy Guides, Enforcement Reports, Talk Papers, Import Alerts, Investigations Operations Manual, Regulatory Procedures Manual, selected Compliance Programs, the Food Code, and listings of approved drug products. The Gold Disk is not releasable under FOI and is not available to the public. It is for FDA use only. The subset of the Gold Disk available to state and local agencies (but not releasable under FOI) is the Eureka Disk. To order this, contact the ORA Office of Partnerships.

1.10.2.5 - FDA/ORA Manuals and Reports

ORA headquarters and the OC Office of Information Resources Management support a change to electronic manuals, not paper manuals, because electronic manuals are easier to issue, revise and distribute. As part of the ORA Quality Management System, ORA HQ supports electronic manual dissemination through developing Intranet master lists or indices for directives used by ORA. See the FDA Intranet for more information. During transition from paper to electronic manuals, a limited selection and number of paper manuals will be available as follows:

  1. Compliance Policy Guides (CPGs): A limited number of paper manuals are available by contacting the Office of Policy and Risk Management (OPRM)
  2. Compliance Program Guidance Manual (CPGM): No paper manuals;
  3. Data Codes Manual: No paper manuals; for electronic lists of program assignment codes and establishment type codes contact OPRM/Division of Planning Evaluation and Management
  4. Enforcement Reports: No paper reports;
  5. Field Management Directives (FMDs) - No paper manual;
  6. Guide to International Inspections and Travel - No paper manual
  7. Inspection Technical Guides - No paper manuals;
  8. International Cooperative Agreements Manual - No paper manuals;
  9. Investigations Operations Manual (IOM) - Current edition paper manuals available by contacting ORA/OO/OMPTO/Division of Medical Products and Tobacco Program Operations
  10. Laboratory Manual (LM) - No paper manuals;
  11. Laboratory Information Bulletins (LIB) - Available on Intranet and eLexnet; Hard Copies available to Labs through ORS
  12. Regulatory Procedures Manual (RPM) - No paper copies;
  13. Recalls and Safety Alerts - No paper copies;
  14. Staff Manual Guide: No paper manuals;
  15. State and Federal Cooperative Agreements: No paper copies.

1.10.2.6 - Forms and other Publications

The FDA on line Public Forms Catalog contains a list of FDA forms and the information necessary to order them.

Paper copies of the forms may be ordered electronically from the Program Support Center. To submit a forms request, or for other questions concerning FDA forms, see http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/ucm236184.htm.

The Department of Health and Human Services (DHHS) Program Support Center, 16071 Industrial Drive, Gaithersburg, MD 20877 maintains a limited selection of FDA forms and publications. To search their catalog, see https://propshop.psc.gov/shopping/formspubs.asp#/. For questions about forms, contact Lisa Sneed at PSC at 301-594-0545. For questions about publications, contact Diana Mathews at PSC at 301-594-0189.

The INTRANET FDA's Electronic Forms Catalog is another resource. Internal forms related to field operations are located at that site. For example, you can find seals, affidavits, Form FDA 482 Notice of Inspection, and many other forms on which FDA documents its activities related to investigations, inspections and sample collection and analysis. Forms are organized alphabetically as well as by form number.

1.10.2.7 - Regulatory References and the General Public

The general public must make a request under the Freedom of Information Act (FOIA) in order to obtain certain FDA documents requiring redaction. See IOM 1.4.4 (Freedom of Information Act) and IOM 1.4.5 (internal FDA documents) for additional information on FOIA. For instructions to the public on how to file an FOIA request, see http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm.

Many FDA documents are available to the public without an FOIA request. To obtain forms, direct the public to the FDA Public Use Forms web page. The public can purchase paper editions of various agency manuals, such as the Food Code and Compliance Program Manuals if ordered by NTIS item number from the National Technical Information Service (NTIS). Instruct the person seeking a publication to first locate the NTIS item number by calling the NTIS sales department at 888-584-8332. The next step is to enter the NTIS item number in the search box at the NTIS website at www.ntis.gov, and follow directions on ordering the publication. For additional information on NTIS publications, direct the public to contact:

National Technical Information Service
Technology Administration
U.S. Department of Commerce
Alexandria, VA 22312
Order Desk: 703-605-6050
customerservice@ntis.gov

The public may also obtain federal publications from the U.S. Government Bookstore on-line.

FDA references are available to the public in electronic format from the FDA website. From the FDA homepage, link to special information for consumers, industry, health professionals, patients, state and local officials. For example, direct industry to the FDA industry web page.

Those regulated by FDA may contact their ORA Regional Small Business Representative (SBR) for an explanation of how FDA requirements apply to specific circumstances. SBRs also locate relevant references, make referrals, conduct or participate in workshops and conferences, or make non-regulatory audits on request.

Direct industry inquiries in accordance with District policy, either to appropriate District personnel, to the ORA Small Business Representative for your region, to an FDA industry assistance office or the Center Ombudsman, or to the Office of the Commissioner. In CDRH, the Division of Manufacturers, International and Consumer Affairs (DSMICA) staff specializes in industry assistance. For FDA drug manufacturing queries, a list of resource staff in the CDER Office of Manufacturing and Product Quality, (HFD-320) identifies each staff member by area of knowledge. Refer questions about good clinical practice requirements to the FDA's GCP staff.

Refer consumer inquiries to the appropriate District Public Affairs Specialist.

Try to refer appropriately to make your government work more effectively for all concerned.

1.10.2.8 - Acronyms

To access explanations for some of the hundreds of acronyms in FDA references, try the following:

  1. FDA Acronyms and Abbreviations database
  2. CFSAN Abbreviations and Acronyms from the CFSAN Risk Analysis Working Group Report "Initiation and Conduct of All Major Risk Assessments within a Risk Analysis Framework" (3/02)
  3. Listeria monocytogenes Risk Assessment report: Abbreviations and Acronyms
  4. ORA Glossary of Computerized System and Software Development Terminology
  5. Fiscal Year 2001 Performance Plan, FY 2000 Final Performance Plan, and FY 1999 Performance Report Glossary of Acronyms
  6. Fiscal Year 2004 Annual Performance Plan, FY2003 Revised Performance Plan, FY 2002 Annual Performance Plan see Appendix F Glossary of Acronyms at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/PerformancePlans/UCM133819.pdf.

1.10.3 - SPECIAL REGULATORY INFORMATION BY PRODUCT CATEGORY

Information including product databases, inspection guides, industry guidance, and regulatory references are available by product category on-line at DMPTO’s intranet site.

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