Get Ca Cdph 8595 2020-2025

The CA CDPH 8595 form is essential for individuals and organizations seeking a drug manufacturing license in California. Completing this application accurately is crucial for a successful submission.

Follow the steps to complete the CA CDPH 8595 online.

1. Click ‘Get Form’ button to obtain the form and open it in the editor.
2. Indicate the nature of your application by selecting whether you are a new applicant, a renewal applicant, or applying due to an ownership change or relocation.
3. Fill in the Name of Firm with the full name of the business applying for licensure.
4. If applicable, enter the DBA (Doing Business As) name of your firm, using additional sheets if necessary.
5. Provide the Facility Address, including the number, street, city, state, and ZIP code.
6. Complete the Mailing Address section if it differs from the Facility Address. Include city and ZIP code.
7. Specify the country where the facility is located, if not in the United States.
8. Enter the website URL for your business if applicable.
9. Select the applicable boxes under Interstate Commerce to identify your business's involvement in shipping and receiving drugs.
10. Choose the appropriate Type of Ownership, ensuring to attach evidence of ownership.
11. Fill in the Owner’s Name or Corporate Name and the State of Incorporation as applicable.
12. List additional Owners or Officers' Names and Titles, using extra sheets if necessary.
13. Include the Associated California Board of Pharmacy License Number if applicable.
14. Indicate the size of the facility (in square feet) and the number of employees.
15. Select the Intended Drug Destinations by checking all applicable boxes regarding your products.
16. Indicate the Type of Product by selecting the appropriate options.
17. Identify the Drug Products Manufactured at your location by checking all relevant boxes.
18. Describe the Manufacturing Processes or activities, indicating if they will be done in-house or by a contract, and list additional processes if needed.
19. Fill out the Payment Code section by selecting the applicable fees and calculating the Total Amount Due.
20. If you meet any criteria for an inspection waiver, indicate this and attach the required documentation.
21. Sign the application, ensuring to print your name, title, and date.
22. Provide the Business Operator's and Correspondent's information accurately.
23. After completing the form, save your changes, and consider downloading, printing, or sharing the completed license application.

Complete your CA CDPH 8595 application online today to ensure a smooth application process.