Firm Profile
FEI Number
Firm Name
Firm Address
Inspections
Inspection Classifications by Fiscal Year
Inspection Classifications by Type
Inspections Details Popup with Inspections-related terminology Help
Inspections Citations Details
*Citations data include Form FDA 483 citations and may not necessarily represent citations on final classification letters.
Published 483s Details
*Published 483s are available in the FDA Reading Room at OII FOIA Electronic Reading Room.
Compliance Actions
Actions by Percentage
Compliance Actions Details
Import Alerts
- Search results are based on an exact match of the Firm FEI Number mapped to the Firm or in some cases, the Surviving Firm. Users should review the search results to determine whether the firm appears in the Import Alert and that the firm's products are allowed into the country. The names displayed are from the time of the action and may be different then the name displayed on the page.
- Only current/active Import Alerts are displayed. Import Alert data on the Dashboard is updated weekly, for the most current Import Alert Data see Import Alerts.
Import Alerts Details
Warning Letters
Warning Letters Details
*Search results are based on an exact match of the Firm FEI Number mapped to the Firm or in some cases, the Surviving Firm. The search results displayed should be reviewed to determine whether the firm is directly or indirectly referenced in the Warning Letter. The names displayed are from the time of the action and may be different than the name displayed on the page.
*Warning Letters issued in the last 5 years are displayed. Warning Letters on this page are refreshed weekly, for more information see Warning Letters.
Caveats:
- Certain information in these datasets may not be presented or may have changed since the posting. The datasets are updated weekly and only include final actions. If you need to present more recent or more complete data for official purposes or have questions about obtaining other data, please contact the Division of Freedom of Information about what materials may be available in electronic reading rooms or inquire about other datasets that would satisfy your needs.
- Inspections and Citations data are only posted for inspections where all project area classifications are finalized.
- Compliance data provide information on a subset of the actions used by the FDA to bring firms into compliance, specifically data pertaining to Warning Letters, Seizures, and Injunctions. The compliance actions disclosed include only finalized and completed actions and are primarily used in the domestic arena.
- More than one establishment may be associated with one compliance action. The counts provided in this section reflect the number of establishments linked to the compliance action.
- For more information regarding the Center for Tobacco Products (CTP) issued warning letters click here.
- FDA has removed Medical Device Single Audit Program (MDSAP) audit reports, which are conducted by certified third-party auditors and may be considered in lieu of an FDA surveillance inspection, from the FDA Data Dashboard. FDA has determined that MDSAP audits do not meet the criteria for posting on the FDA Data Dashboard.