Others titles
- FDA Acronyms & Abbreviations
- FDA Acronyms & Abbreviations Database
Keywords
- Drug Safety
- FDA Acronyms
- FDA Abbreviations
- FDA Database
- FDA Inspections
- FDA Establishments
FDA Acronyms and Abbreviations Database
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.
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Description
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.”
About this Dataset
Data Info
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 |
N/A |
Keywords | Drug Safety, FDA Acronyms, FDA Abbreviations, FDA Database, FDA Inspections, FDA Establishments |
Other Titles | FDA Acronyms & Abbreviations, FDA Acronyms & Abbreviations Database |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Definition | Description of Acronyms | string | required : 1 |
Acronym | Acronym Abbreviations | string | - |
Acronym_ID | Unique Acronym Identification | string | required : 1unique : 1maxLength : 4 |
Data Preview
Definition | Acronym | Acronym ID |
Biologics Regulatory Management System | BRMS | 1 |
body surface area | BSA | 2 |
bovine spongiform encephalopathy (mad cow disease) | BSE | 3 |
bovine somatotropin | BST | 4 |
British Veterinary Codex | BVC | 5 |
culture and sensitivity | C & S | 6 |
certificate of analysis | C of A | 7 |
Chemical Abstracts | CA | 8 |
Carcinogenicity Assessment Committee (CDER) | CAC | 9 |
Center ADP/TC Computer Tracking and Inventory System (CFSAN) | CACTIS | 10 |