Firm Profile
FEI Number
Firm Name
Firm Address
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Inspections
Inspections
Classifications
Inspection Classifications by Fiscal Year
Inspection Classifications by Type
Inspections Details
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Inspections Citations Details
*Citations data include Form FDA 483 citations and may not necessarily represent citations on final classification letters.
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Compliance Actions
Warning Letters
Injunctions
Seizures
Actions by Percentage
Compliance Actions Details
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Import Alerts
- Search results are not returned based on an exact match of the firm name. 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.
- Only current/active Import Alerts are displayed. For more information see Import Alerts.
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Warning Letters
- The search results below should be reviewed to determine whether the firm is directly or indirectly referenced in the Warning Letter.
- Only Warning Letters issued in the last 5 years are displayed. 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.
- 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.