Terms and Definitions

Action Type:

Warning Letter – For information about warning letters or to access the redacted warning letters please see the Warning Letters page. For information on the procedures related to warning letters, please see the Regulatory Procedures Manual.

Seizures – For information on the procedures related to seizures, please see the Regulatory Procedures Manual.

Injunctions – For information on the procedures related to injunctions, please see the Regulatory Procedures Manual.

Programs/Centers:

CBER
Biologics Program. Center for Biologics Evaluation and Research

CDER
Human Drugs Program. Center for Drug Evaluation and Research

CDRH
Devices and Radiological Health Program. Center for Devices and Radiological Health

CFSAN
Foods & Cosmetics Program. Center for Food Safety and Applied Nutrition

CVM
Animal Drugs & Feeds Program. Center for Veterinary Medicine

CTP
Tobacco Products Program. Center for Tobacco Products

Direct Reference Program:

"Direct Reference" is a situation whereby the Center grants the Districts 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).

District Decision/Classification:

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

• OAI – Official Action Indicated
• NAI – No Action Indicated
• VAI – Voluntary Action Indicated

FEI Number:

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.

Fiscal Year (FY):

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 2009 begins on October 1, 2008 and ends on September 30, 2009

Inspection End Date:

The date the inspection at the facility was concluded.

Project Area:

For a description of each project area, see Inspection Project Area Listings.

Recall Classifications:

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.