The CDRH Inspections Database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present.
A single inspection may have aspects that are handled by Office of Regulatory Affairs (ORA) and other aspects that are handled by CDRH. Only inspections where CDRH has responsibility (including collaboration on the warning letter) are included in this inspection search page. The inspection search page provides access to approximately 25% of the medical device inspections conducted since 2008.
The types of inspections where CDRH is responsible are defined in the Regulatory Procedures Manual section 4-1-4. The inspection types include areas such as foreign inspections, Medical device Reporting (MDR) malfunction issues, labeling and software issues.
Clinical Trial inspections are not included in this database because information about new medical device development is confidential.
The database contains information about the firms, types of devices and inspections, and links to warning letters (when available).
You can search the Inspection database by Company Name, Country, Medical Specialty, Inspection Type, Product Code, Inspection Classification, Inspection Action, District, or Date.
To search for a firm using the company name:
- Type the Company Name in the field
- Click the Submit button
- A list of inspections matching your criteria are displayed
- Click on the underlined Establishment Name
- The inspection classification, action and additional information are displayed
- Click on the warning letter link to get warning letters for the identified company
- Click on the New search link to return to the search screen
Notes about Searching:
You may generate a list of the entire CDRH Inspections Inventory by clicking on the Submit button without specifying any search criteria.
Company Name: users may enter partial words contained in the name of the company. The company name field is not case sensitive, i.e. the search will return the same results if the user enters "Anderson" or "anderson".
Final Decision Date: enter a date range in the From and To fields in the format of mm/dd/yyyy. The From date must be earlier than the To date. To search on a specific date, enter the same date in the From and To fields.
For more information on medical device inspections please refer to FDA Guidance document, Inspection of Medical Device Manufacturers http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
Search CDRH Inspections Database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/inspect.cfm