​Drug and Medical Device Manufacturer Licensing Information

All Applicants

• The Food and Drug Branch (FDB) will only release application status information to the owner or authorized representative on file.
• To add an authorized representative, submit a signed request on company letterhead or via a company email.
• The request must include the representative's name and contact information (email address, and/or phone number) and be submitted by the owner or authorized signatory.

Renewal Applicants

• It is the firm's responsibility to renew its license in a timely manner.
  
• It is unlawful to operate without a valid license, and firms may be subject to regulatory action.
• Applications are processed in the order received.
• Incomplete applications will delay processing. A deficiency notice will be issued for missing items.
• To avoid delays, ensure the application is complete, signed and includes all required supporting documentation, and the correct fee amount.       

  ​​​​New Applicants

• Please allow approximately 3-4 weeks for initial application review and inspector assignment.
• Applications are assigned in the order received, when an inspection is required.
• The assigned inspector will contact the applicant using the information provided to coordinate the inspection.
• Inspection scheduling is based on the applicant's readiness and the inspector's availability.
  
• When applicable, licenses are issued following a satisfactory inspection and final review for compliance with applicable laws and regulations.
• License certificates are mailed after inspection approval. Please allow approximately 2 weeks for delivery.

​ Ownership Changes and Facility Relocations

• Licenses are site specific and are non-transferable.
• A change in ownership or facility relocation requires the submission of a new application.
• A new application and inspection are required for ownership changes or relocations. (In certain cases, specific criteria may apply in lieu of an inspection for Medical Device or Drug Manufacturers. Please refer to the appropriate application guidance)

Name Change and Doing Business As (DBA)

• Submit a completed application with a $15.00 check or money order, or cashier's check.
• Clearly indicate “Name Change Only" on the application
• Provide supporting documentation:
  
• Legal name changes: Documentation from the Secretary of State.
• ​​Fictitious Business Name (DBA): Documentation filed with the County Clerk/Recorders Office.

​License Verification Requests

• License verifications may be requested by email or mail.
• Submit requests to FDBMedDevice@cdph.ca.gov or mail to the Branch.
• You may include Form CDPH 8707​ with your request.​
  

Payment Information

• All fees are non-refundable.
• FDB does not accept online payments. Payments must be made by check, cashier's check, or money order.
• Confirm with your financial institution when your payment has been cleared; this serves as confirmation that your application has been received and is in process.
• Payments received without corresponding application or supporting documentation will be returned to the address listed on the payment.
  

License Certificates

• Licenses are mailed via United States Postal Service (USPS) regular mail (no tracking information provided).
  
• Please allow up to 7-10 days upon license issuance to receive your certificate in the mail. If you have not received anything in the mail after 14 days, you may request a duplicate copy.
• Requests for duplicate certificates made after issuance made more than 90 days after issuance require a written request and $15.00 fee per copy. ​​​