California Department of Public Health - Food and Drug Branch


Please Note

We are a service company that can help you file with the California Department of Public Health - Food and Drug Branch. We are not associated with this nor any other government agency. We offer paid services and software to help you file. You are not required to purchase our service to file - you may file directly with this agency without using our service.


Contact Information

Mailing address:
P.O Box 997435
Sacramento, CA 95899-7435

Phone: (800) 495-3232

Web: Home
Email: FDBinfo@cdph.ca.gov

Licenses

We track the following licenses with the California Department of Public Health - Food and Drug Branch in order to provide compliance services to our clients. As a client, you see this and other Compliance Core™ data in License Manager in-line with your licenses.

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California Drug Manufacturing License

Agency:California Department of Public Health - Food and Drug Branch

Initial Registration

Form:

Form CDPH 8595: Drug Manufacturing License Application: New Applicant, Ownership Change, Renewal, and Relocation

Agency Fee:

$4,187 application fee + $200 PDMA fee (if applicable).

Original Ink:Not Required

Registration Renewal

Form:

Form CDPH 8595: Drug Manufacturing License Application: New Applicant, Ownership Change, Renewal, and Relocation (Renewal)

Agency Fee:

$4,187 renewal fee + $200 PDMA fee (if applicable).

Due:

Biennially

Original Ink:Not Required

California Home Medical Device Retailer Exemptee License

Agency:California Department of Public Health - Food and Drug Branch

Initial Registration

Form:

Home Medical Device Retailer Exemptee License: CDPH 8695

Agency Fee:

$403

Original Ink:Not Required

Registration Renewal

Form:

Home Medical Device Retailer Exemptee License: CDPH 8695 (Renewal)

Agency Fee:

$242

Due:

Annually

Original Ink:Not Required

California Home Medical Device Retailer License

Agency:California Department of Public Health - Food and Drug Branch

Initial Registration

Form:

Home Medical Device Retailer License Application: CDPH 8679

Filing Method:

Mail

Agency Fee:

$1,509 base fee + $754 warehouse fee (if applicable)

Original Ink:Not Required

Registration Renewal

Form:

Home Medical Device Retailer License Application: CDPH 8679 (Renewal)

Filing Method:

Mail

Agency Fee:

$1,509 base fee + $754 warehouse fee (if applicable)

Due:

Annually by the registration anniversary date.

Original Ink:Not Required

California Home Medical Device Retailer License - Warehouse Only

Agency:California Department of Public Health - Food and Drug Branch

Initial Registration

Form:

Home Medical Device Retailer License Application: CDPH 8679

Agency Fee:

$686

Original Ink:Not Required

Registration Renewal

Form:

Home Medical Device Retailer License Application: CDPH 8679 (Renewal)

Agency Fee:

$686

Due:

Annually by the registration anniversary date.

Original Ink:Not Required

California Medical Device Manufacturing License

Agency:California Department of Public Health - Food and Drug Branch

California Out-of-State Home Medical Device Retailer Registration

Agency:California Department of Public Health - Food and Drug Branch
Qualifying Individual Requirements:

A California-licensed Pharmacist-in-charge or licensed exemptee

Initial Registration

Form:

Out-of-State Home Medical Device Retailer Registration: CDPH 8679

Agency Fee:

$242

Original Ink:Not Required

Registration Renewal

Form:

Out-of-State Home Medical Device Retailer Registration: CDPH 8679 (Renewal)

Agency Fee:

$242

Due:

Annually by the registration anniversary date.

Original Ink:Not Required

California Processed Food Registration

Agency:California Department of Public Health - Food and Drug Branch

Initial Registration

Form:

Processed Food Registration

Agency Fee:

Fees depend on the size of facility (for warehousing) or number of employees (for manufacturing, repacking, labeling, or salvaging processed foods). See the application for details.

How to Apply:
  1. Application (including check for fees) is received by the California Department of Public Health (CDPH) mailroom and delivered to the FDB via the MS Code or P.O. Box listed on the envelope.
  2. After the FDB receives the envelope containing the application and fees, it is given to the Cashiering Desk (CD) to log and then sent to the CDPH Accounting office for the check to be deposited.
  3. FDB CD gets the receipt back from CDPH Accounting stating it was deposited and the application is then forwarded to the FDB Licensing Desk (LD).
  4. FDB LD receives the application from FDB CD and starts screening it for completeness.
    1. If an application is deemed complete, it will be entered into the Program’s system and sent to the FDB Inspection team.
  5. The inspection team receives the application, and it is screened for operational details and placed in the queue to be assigned to an inspector.
  6. An inspector contacts the firm for a pre-registration “new license inspection.”
    1. The firm must tell the inspector if it’s ready for inspection (i.e., not undergoing construction, equipment set up, not undergoing a city/county plan check, or lacking required HACCP documentation when applicable, etc.).
    2. Inspection schedules are based on the priorities and workload of the assigned Food Safety Inspector.
  7. Once an inspection is completed, the District Office Supervisor reviews the reports and findings, and sends a disposition to the Licensing Desk.
  8. The Licensing Desk will generate the license, if the disposition is to issue the license, and mail out to the firm to the address provided on the application. 

Registration Renewal

Form:

Processed Food Registration (Renewal)

Agency Fee:

Fees depend on the size of facility (for warehousing) or number of employees (for manufacturing, repacking, labeling, or salvaging processed foods). See the application for details.

Due:

One year from the date of the food safety inspection.

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