FDA Acronyms and Abbreviations Database

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Food and Drug Administration (FDA) conducts inspections of establishments that manufacture, process, pack, or hold FDA-regulated products, before approving products and/or after products are on the market, to determine the establishment’s compliance with the FDA laws. This document is called an FDA Form 483, which includes the name of the firm and the date(s) of inspection, and lists the observations made by the investigator during the inspection when there are objectionable conditions.

Complexity

Several comments from both industry and consumer groups requested that Food and Drug Administration (FDA) make all inspection reports available online in a timely fashion. Some comments suggested that inspection results should be posted within 24 hours after an inspection of a food facility is completed; another comment requested that FDA inspectional observations be posted and made available for review within 30 days of the inspection being concluded. A comment from a consumer group suggested that FDA disclose a summary page of key inspection results after each food facility inspection and noted that this format appeared to be used successfully in another country.

Some comments specifically noted that the reports should only be posted after the proprietary information has been redacted. A comment from industry noted that “these inspectional findings help the industry to understand the expectations of the agency and are significant tools for industry to ensure that compliance training and programs are in step with FDA.” Many comments bemoaned the time it takes to obtain inspection information through the FOIA process.

An industry comment suggested FDA provide additional information about inspection trends and “FDA’s concerns that may drive inspectional
observations and other citations.”

Date Created

2012

Last Modified

2017-08-01

Version

2017-08-01

Update Frequency

Irregular

Temporal Coverage

N/A

Spatial Coverage

United States

Source

John Snow Labs; Food and Drug Administration (FDA);

Source License URL

Source License Requirements

N/A

Source Citation

NA

Keywords

Drug Safety, FDA Acronyms, FDA Abbreviations, FDA Database, FDA Inspections, FDA Establishments

Other Titles

FDA Acronyms & Abbreviations, FDA Acronyms & Abbreviations Database

NameDescriptionTypeConstraints
DefinitionDescription of Acronymsstringrequired : 1
AcronymAcronym Abbreviationsstring-
Acronym_IDUnique Acronym Identificationstringrequired : 1 unique : 1 maxLength : 4
DefinitionAcronymAcronym ID
Biologics Regulatory Management SystemBRMS1
body surface areaBSA2
bovine spongiform encephalopathy (mad cow disease)BSE3
bovine somatotropinBST4
British Veterinary CodexBVC5
culture and sensitivityC & S6
certificate of analysisC of A7
Chemical AbstractsCA8
Carcinogenicity Assessment Committee (CDER)CAC9
Center ADP/TC Computer Tracking and Inventory System (CFSAN)CACTIS10