See FDA.gov Inspections Database Frequently Asked Questions
| Data Source | Notes |
| Inspection Observations | These spreadsheets are not a comprehensive listing of all inspectional observations but represent the area of regulation and the number of times it was cited as an observation on an FDA Form 483 during inspections conducted by FDA and its representatives. Inspectional observations reflect data pulled from FDA’s electronic inspection tools. These tools are used to generate the FDA Form 483 when necessary. Not all FDA Form 483s are generated by these tools as some 483s are manually prepared. See: https://www.fda.gov/ICECI/Inspections/ucm250720.htm |
| Food and Drug Recalls | This is the openFDA API endpoint for all food product recalls monitored by the FDA. When an FDA-regulated product is either defective or potentially harmful, recalling that product – removing it from the market or correcting the problem – is the most effective means for protecting the public. Queries are real-time to openFDA, an FDA beta research project and not for clinical use. FDA may limit or otherwise restrict access to the API in line with their Terms of Service. See: https://open.fda.gov/food/enforcement/ |
| Food and Drug SAERs | An adverse event is submitted to the FDA to report adverse health effects and product complaints about foods, dietary supplements, and cosmetics. These may include side effects, product use errors, and product quality problems. Reporting is voluntary for beverages, conventional foods, dietary supplements, and cosmetics, which means that manufacturers and citizens may report them at any time but are not obligated to. For dietary supplements, manufacturers, packers, and distributers must notify the FDA if they receive reports about serious adverse events in connection with the use of their products. See https://open.fda.gov/food/event/ |
| Warning Letters | Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. See: http://www.accessdata.fda.gov/scripts/warningletters/wlSearchExcel.cfm |
| Inspection Classifications | Inspections are classified to reflect the compliance status of a firm. Classifications are based upon findings identified during an inspection and Agency review for compliance. During the Agency assessment, classifications may be subject to change after a review of all relevant information. To maintain current knowledge of a firm’s compliance status, it may be important to recheck the Inspections Database for updates. The disclosure of this information is not intended to interfere with planned enforcement actions, therefore some information may be withheld from posting until such action is taken. Therefore, this database does not represent a comprehensive listing of all conducted inspections and should not be used a source to compile official counts. See: http://www.fda.gov/ICECI/Inspections/ucm222557.htm |
| Inspections Citations (Form 483 Observations) |
Citations data contained in the FDA spreadsheets used to generate this database reflect data pulled from FDA’s electronic inspection tools. These tools are used to generate the FDA Form 483 when necessary. Not all FDA Form 483s are generated by these tools as some 483s are manually prepared. In addition, if changes were made to the FDA Form 483 and not synchronized with the electronic inspection tools, the results will not fully reflect the actual final Form 483 that was provided to the firm. See: http://www.fda.gov/ICECI/Inspections/ucm346077.htm |
| Tainted Products | Disclaimer: This list only includes a small fraction of the potentially hazardous products with hidden ingredients marketed to consumers on the internet and in retail establishments. FDA is unable to test and identify all products marketed as dietary supplements on the market that have potentially harmful hidden ingredients. See: http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder |