Glossary: FDA Data Dashboard
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:
CDRH
Devices and Radiological Health Program. Center for Devices and Radiological Health
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.
Where do I find my FEI number?
A business entity may receive a D-U-N-S number in approximately 10 business days for an expedited service fee. Facility Establishment Identifier (FEI), a unique identifier designated by FDA to assign, monitor, and track inspections of regulated firms.
How do I find my FDA establishment number?
Since there is no publicly available database , it is not possible to find your registration number online. However, if you are owner of the facility, you can contact FDA and get your registration details.
How do I find my FDA FEI number?
To obtain an FEI number for a GDUFA-related facility, email [email protected]. To obtain an FEI number for a PDUFA- or BsUFA-related facility, email [email protected]. Note: An FEI number is a facility specific identifier.
What does an FEI number look like?
The FEIN number is a unique, nine-digit number that identifies businesses operating in the United States. The IRS structures the federal tax identification number in an XX-XXXXXXX format.
What is FDA DUNS number?
D-U-N-S Number. D-U-N-S® Number. FDA may assign a D-U-N-S® Number to a registrant, establishment, importer, and U.S. agent to a foreign firm. A D-U-N-S® number is a unique, universal, 9-digit identifier used to identify and verify business information for a specific entity. Ask the FDA for more information.
What is the FDA registration number?
The US FDA will assign a unique registration number to each registered food facility, the assignment of FDA registration number does not denote the approval of your establishment or product by the US FDA. The FDA registration number only recognizes that, your establishment is registered with US FDA.
How many digits is FDA registration number?
11 digits
FDA registration number and PIN code -FDA number is 11 digits, PIN code is combination of upper case, lower case letters and numbers.
How do I get an FDA number?
Initial Registration. Make payment and obtain the Payment Identification Number (PIN) and the Payment Confirmation Number (PCN) at the Device Facility User Fee website. Go to FURLS at https://www.access.fda.gov/oaa/.
How many digits is an FEI number?
nine
The FEIN is a unique nine-digit corporate ID number that works the same way a Social Security number does for individuals. The tax number for individuals, also referred to as a tax identification number or TIN, is an individual’s Social Security number.
Is Ufi the same as DUNS number?
What is the FDA recognized form of Unique Facility Identifier (UFI) and how to obtain it? Currently, FDA only recognizes the Data Universal Numbering System (DUNS) number as an acceptable form of UFI. DUNS numbers are assigned and managed by Dun & Bradstreet; a US-based firm with global offices.
Why does FDA require DUNS number?
Data Universal Number Systems, commonly known as DUNS are unique, site specific, nine-digit identification numbers provided by Dun & Bradstreet (D&B) and used globally. Free to obtain, FDA and other federal agencies use DUNS numbers to track and verify company name, address, phone number, URL, etc.
How do I get an FEI number?
To obtain an FEI number for a GDUFA-related facility, email [email protected]. To obtain an FEI number for a PDUFA- or BsUFA-related facility, email [email protected]. Note: An FEI number is a facility specific identifier.
How do I find my FDA establishment number?
Since there is no publicly available database , it is not possible to find your registration number online. However, if you are owner of the facility, you can contact FDA and get your registration details.
What is a firm establishment identifier?
An FDA Establishment Identifier or Firm Establishment Identifier (FEI) is an FDA system generated number used to identify a firm. FEI numbers associated with a specific address or. Address associated with a FEI number for a firm already in FDA’s firm inventory.
Is FEI number same as FDA registration number?
An FDA Establishment Identifier (FEI) Number is issued to track inspections of regulated medical device or drug establishments. Unlike the FDA Registration Number, the FEI has 10 digits.
What does an FEI number look like?
The FEIN number is a unique, nine-digit number that identifies businesses operating in the United States. The IRS structures the federal tax identification number in an XX-XXXXXXX format.
Is FEI number same as tax ID?
Yes, the FEIN (Federal Employer Identification Number) is the same as the EIN which stands for Employer Identification Number.
What is an FDA establishment number?
The US FDA will assign a unique registration number to each registered food facility, the assignment of FDA registration number does not denote the approval of your establishment or product by the US FDA. The FDA registration number only recognizes that, your establishment is registered with US FDA.
What is FDA registered facility?
FDA Registration Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States are generally required to register annually with the FDA.
What is an FDA establishment identifier?
An FDA Establishment Identification (FEI) number is a unique identifier issued by FDA to track inspections of the regulated establishment or facility. FEI numbers are also used to track GDUFA facility fee payments.
How do I get a DUNS number for FDA?
To date, the FDA recognizes the Data Universal Numbering System (DUNS) number as an acceptable UFI. The DUNS number is assigned and managed by Dun & Bradstreet (D&B). DUNS numbers can be obtained or verified by visiting D&B’s website at http://www.dnb.com/duns-number.html .
What is FDA establishment identifier?
1. What is an FDA Establishment Identification number? An FDA Establishment Identification (FEI) number is a unique identifier issued by FDA to track inspections of the regulated establishment or facility. FEI numbers are also used to track GDUFA facility fee payments.
Is Fei and EIN the same?
Essentially, a FEIN and an EIN are the same. FEIN. FEIN stands for “federal employer identification number.”
Fei number что это
FDA Establishment Identifier
Companies (also called establishments) that are involved in the production and distribution of medical devices intended for use in the United States, are required to register annually with the U.S. Food and Drug Administration.
Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA, and list all of their commercially marketed drug products.
Having an FDA Establishment Identifier (FEI) Number and DUNS Number will facilitate the application process and establishment registration.
Section 510 of the Food, Drug, and Cosmetic Act requires that each initial and annual drug establishment registration include a Unique Facility Identifier (UFI) .
FDA’s preferred Unique Facility Identifier (UFI) is the DUNS Number , assigned and managed by Dun & Bradstreet Inc, for:
▪ Drug, medical device or cosmetic establishment.
At the time of the registration, the owner or operator should obtain an FDA Establishment Identification (FEI) Number or Firm Establishment Identifier Number, because it is a unique identifier issued by the FDA to track:
▪ Inspections of regulated establishments or facilities.
▪ User Fees payments.
▪ Entities within the imports message set, during customs clearance.
Keep in mind that the FEI is usually assigned subsequent to or following the registration , and expect several business days or longer.
Finally, please note that an FEI Number is different from an Employer Identification Number (EIN), also known as a Federal Tax Identification Number, used to identify a business entity.