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Glossary

The objective of FDA regulatory programs is to ensure compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specific enforcement activities include actions to correct and prevent violations, remove violative products or goods from the market, and punish offenders.

The type of enforcement activity FDA uses will depend on the nature of the violation. The range of enforcement activities may include:

  • letter notifying the individual or firm of a violation and requesting correction
  • recall, seizure, or injunction
  • administrative detention
  • civil money penalties
  • criminal prosecution of the individual or firm.

Warning Letter

A Warning Letter is the Agency's principal means of achieving prompt voluntary compliance with the FD&C Act. The use of Warning Letters is based on the expectation that most individuals and firms will voluntarily comply with the law.

Warning letters are considered advisory actions, and the FDA’s position is that these letters are issued only for violations of regulatory significance. Significant violations are those violations that may lead to enforcement action if not promptly and adequately corrected. As a result, these letters request a written response as to the steps which will be taken to correct the violation.

Despite the significance of the violations, there are some circumstances that may preclude the Agency from taking any further enforcement action following the issuance of a Warning Letter. For example, the violation may be serious enough to warrant a Warning Letter and subsequent seizure; however, if the seizable quantity fails to meet the Agency's threshold value for seizures, the Agency may choose not to pursue a seizure. In this instance, the Warning Letter would document prior warning if adequate corrections are not made and enforcement action is warranted at a later time.

Warning Letters issued to individuals and firms can be found on the Warning Letters page. For information on the procedures related to warning letters, please see the Regulatory Procedures Manual.

Injunction

FDA may seek injunctions against individuals and/or corporations to prevent them from violating or causing violations of the FD&C Act. An injunction is a civil judicial process initiated to stop or prevent violation of the law, such as to halt the flow of violative products in interstate commerce, and to correct the conditions that caused the violation to occur. See 21 U.S.C. 332; Rule 65, Rules of Civil Procedure. For information on the procedures related to injunctions, please see the Regulatory Procedures Manual, Chapter 6.

Seizure

An action brought against an FDA-regulated product because it is adulterated and/or misbranded within the meaning of the FD&C Act. The purpose of such an action is to remove specific violative goods from commerce. Adulteration or misbranding is usually the result of an individual failing to take steps to ensure compliance with the law. Such an individual may be liable for a violation of the FD&C Act and, if found guilty, be subject to the penalties specified by the law. For information on the procedures related to seizures, please see the Regulatory Procedures Manual, Chapter 6.

The definition of each District/Division Decision can be found in the Establishment Inspection Report (EIR) ORA Field Management Directive 86. The District/Division Decision is also known as an inspection classification.

FDA discloses inspection information on the Inspections Database page. For this data set, FDA is specifically disclosing the final inspection classification for inspections conducted of clinical trial investigators, Institutional Review Boards (IRB), and facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed. The disclosure of this information is not intended to interfere with planned advisory or enforcement actions, and some information may be withheld from posting until such action is taken.

Inspections are classified based upon findings identified during an inspection and Agency review for compliance and are assigned a value from the table below.

Decision Classification and Acronym
Classification Acronym
No Action Indicated NAI
Voluntary Action Indicated VAI
Official Action Indicated OAI

The OAI classification, though the worst classification, does not mean that an advisory or enforcement action will be taken. It is important to note that an OAI classification may be due to reasons other than food safety; for example, issues with nutritional or ingredient labeling may result in an OAI classification.

FEI is an acronym which stands for FDA Establishment Identifier. It is also known as the Firm or Facility Establishment Identifier. The FEI number is a unique identifier assigned by the FDA to identify firms associated with FDA regulated products.

The fiscal year is the accounting period for the federal government which begins on October 1 and ends on September 30. The fiscal year is designated by the calendar year in which it ends: for example, fiscal year 2017 begins on October 1, 2016 and ends on September 30, 2017.

The date the inspection at the facility was concluded.

FDA is responsible for:

  • Protecting the public health by ensuring that foods (except for meat from livestock, poultry and some egg products which are regulated by the U.S. Department of Agriculture) are safe, wholesome, sanitary and properly labeled
  • Ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective
  • Protecting the public from electronic product radiation
  • Ensuring cosmetics and dietary supplements are safe and properly labeled
  • Regulating tobacco products
  • Advancing the public health by helping to speed product innovations

FDA's responsibilities extend to the fifty United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions. To support these missions, FDA maintains the product-specific Centers described below:

Center Program and Prototype Mapping
Center Name Program Product Type Acronym
Center for Biologics Evaluation and Research Biologics Program Biologics CBER
Center for Drug Evaluation and Research Human Drugs Program Drugs CDER
Center for Devices and Radiological Health Devices & Radiological Health Program Devices CDRH
Center for Food Safety and Applied Nutrition Foods & Cosmetics Program Food/Cosmetics CFSAN
Center for Veterinary Medicine Animal Drugs & Feeds Program Veterinary CVM
Center for Tobacco Products Tobacco Products Program Tobacco CTP
Direct Reference Program
“Direct Reference” is a situation whereby the Center grants the Districts/Divisions authority to issue a Warning Letter, enjoin firms, or seize products without direct Center review and approval. Those situations are detailed in the Compliance Program Guidance Manual (CPGM).

Program Areas are categories that correspond to the high-level SubChapter(s) and associated Parts of the Code of Federal Regulations and US Federal Food, Drug, and Cosmetic Act.

Project Areas are categories of FDA’s field activities that may be conducted during an inspection. Project Areas are grouped based on the corresponding Center (i.e., Center for Food Safety and Applied Nutrition, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Veterinary Medicine, Office of Regulatory Affairs, and Center for Tobacco Products).

A recall is a firm's removal or correction of marketed products, including its labeling and/or promotional materials that FDA considers to be in violation of the laws it administers. The Agency would initiate legal action (e.g., seizure or other administrative or civil actions available to the Agency) if the product was not recalled. Recalls do not include market withdrawals or stock recoveries.

Recall Classification

A numerical designation (e.g., I, II, or III) that is assigned by FDA to a particular product recall, indicating the relative degree of health hazard.

Recall Classification Description
Classification Description
Class I Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.
Class II Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.
Class III Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.

Recall Status

  • Ongoing

    The classification used to indicate that the recall action is in progress.

  • Completed

    The classification used to indicate that the recalling firm has:

    • Retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or
    • Completed all product corrections.
  • Terminated

    The classification used to indicate that FDA has determined that:

    • All reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and
    • Proper disposition has been made according to the degree of hazard.

Recalling Firm

The firm that initiates a recall. In the case of an FDA-requested recall, the recalling firm is the firm that has primary responsibility for the manufacture and/or marketing of the product to be recalled.

Recall Number

The number assigned to the recall of one product—regardless of package size, lot numbers, or private buyers' labels—provided the labels are otherwise identical.

If a manufacturer requests a wholesaler, distributor, or relabeler to extend the recall to a lower level (assuming no change of the product has occurred), the same recall number assigned to the manufacturer will be used.

If the recalled product has:

  • Undergone a change due to further processing or
  • Is used as an ingredient or component in a new product, or
  • Has had the directions or indications for use changed,

it will be considered a different product and its recall will be the responsibility of the firm responsible for the change. FDA will then assign a separate recall number.