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Consumer Complaint - Food, Drug, or Medical Device

Consumers, health professionals, and Food and Drug Branch-regulated companies can make a difference in public health by reporting any problem associated with foods, drugs, medical devices, cosmetics and certain other consumer products. The California Department of Public Health, Food & Drug Branch (FDB) is responsible for ensuring that these products are safe and not adulterated, misbranded nor falsely advertised and that drugs and medical devices are safe and effective for their intended use.

We need and appreciate your willingness to take the time and effort to assist us in collecting the necessary information to take appropriate action. FDB evaluates each complaint to determine the seriousness of the problem. Action taken by FDB can range from referral to responsible firm for corrective action to immediate investigation to protect the public health.

Background

The Consumer Complaint System collects information on the condition of FDB regulated products which consumers are dissatisfied with. The information is compiled and evaluated to highlight current problems and long term trends. The information is also used as background data in the development of Branch programs.

Complaint Reporting

Please provide the following information when reporting a complaint:

  1. Your name, address (including zip code), and telephone number (including area code).
  2. A clear, brief description of the complaint, illness or injury.
  3. A complete description of the product(s), including brand, product name, size, code(s) or lot number(s).
  4. Name and location where purchased.
  5. Product manufacturer's name and address.

Consumer Complaints can be reported:

By Phone: Toll Free at 1(800) 495-3232 automated 24-hour service

By Fax: (916)650-6650

By Mail: California Department of Public Health
             Food & Drug Branch
             P.O. Box 997435  MS-7602
             Sacramento, CA 95899-7435

If the situation is an emergency that requires immediate action please contact:
Office of Emergency Services 24-hour staffing at (916) 262-1621.
http://www.oes.ca.gov/

If the situation involves suspected botulism please contact your Local Health Department immediately.

How FDB Handles Consumer Complaints

Up on receipt of a consumer complaint, FDB evaluates the report to determine how serious the problem is, and, if necessary, may request additional information from the person who filed the report before taking action. Follow up activities initiated may include contacting the retailer, distributor, and manufacturer to identify the responsible firm, and the facility location. Once the basic information is established, FDB determines if the complaint requires referral to an outside agency. If the complaint is for a product within FDB’s jurisdiction, the appropriate inspection unit is notified.

Food Product Complaints

Food Complaints Not Involving Illness or Injury

Consumer Complaints regarding foods served or sold at retail food facilities that do not involve illness or injury (e.g., cockroach in food served at a restaurant, filth in bulk food bins at a market) are referred to the Local Health Department (LHD). All other food complaints not involving an illness or injury (e.g., swollen cans of tomato sauce, a cupcake with metal fragments in it or "foul" tasting produce) should be referred to FDB for follow-up.

Food Complaints Involving Illness or Injury

Class I (emergency)

This category includes any incident, which presents, or may reasonably be expected to present: (a) serious adverse health consequences including a threat to life, a necessity for immediate medical or surgical intervention by professional medical or health personnel or permanent damage or impairment of a body structure or function; or (b) other adverse health consequences where significant numbers of people are or may be expected to be at risk (e.g., botulism, paralytic shellfish poisoning, or product tampering).

Class I complaints are immediately investigated to protect the public health. CDPH officials and other state or federal agencies are advised as required. If it becomes apparent from investigation that products outside California are affected, the appropriate federal agencies are notified.

Class II (urgent)

This category includes any incident, which presents, or may reasonably be expected to present, other adverse health consequences, which are temporary or medically reversible in nature. (Example: finding a foreign object in a food product.)
Class II complaints are investigated based on the inherent risk of injury that the issue poses. Appropriate CDPH officials and other state or federal agencies are advised as needed.

Class III (other)

This category includes any incident, which presents, or may reasonably be expected to present, no adverse health consequences. (Example: short-fill weight, high fat in hamburger.)  Class III complaints are generally referred to the responsible firm for corrective action. The complaint is most often referred by telephone or letter, and FDB requests to be notified of the follow-up actions taken by the firm. Complaints involving products manufactured out-of-state are coordinated with the appropriate federal agency (e.g., FDA, USDA, or CPSC) for follow-up with the manufacturer.

FDB uses its statutory powers under the California Health and Safety Code including its authority to inspect, take samples, review records, and embargo to investigate complaints.  To the extent possible, FDB solicits the cooperation of industry to resolve complaints but, when necessary, may seek legal action.

Lead Agency for Follow-up Investigation and Risk Management

All Tampering FDB/FDA FDB
Non-Food (e.g., drug, medical device) FDB/FDA FDB
Commercially Processed Foods LHDs FDB
Produce (pesticide related illness) LHDs DPR
Produce (non-pesticide related illness) LHDs FDB
Dairy Products Produced out-of state LHDs FDB/FDA
Dairy Products Produced in California LHDs CDFA, FDA
Meat & Poultry LHDs CDFA, USDA
Shell Eggs LHDs CDFA, USDA, FDB
Seafood & Shellfish LHDs FDB
 
CDFA - California Department of Food & Agriculture
USDA - U.S. Department of Agriculture
DPR - Department of Pesticide Regulation
FDB - CDPH’s Food and Drug Branch
LHDs - Local Health Departments
FDA - U.S. Food and Drug Administration
 
Additional information on the following can be found in your local phone directory:
• Accidental poisonings: Poison control centers or hospital
• Alcoholic beverages: Department of Treasury’s Bureau of Alcohol, Tobacco and Firearms
• Dispensing and sales practices of pharmacies: State Board of Pharmacy
• Drug abuse and controlled substances: Department of Justice’s Drug Enforcement Administration
• Hazardous household products (including toys, appliances, and chemicals): Consumer Product Safety Commission – 1 (800) 638-2772
• Hazardous chemicals in the workplace: U.S. Department of Labor’s Occupational Safety and Health Administration
• Medical practice: Medical Board of California
• Pesticides or air and water pollution: U.S. Environmental Protection Agency
• Restaurant food and sanitation: Local health department
• Unsolicited products in the mail: U.S. Postal Service
• Warranties: Federal Trade Commission

 
 
Last modified on: 1/24/2008 8:25 AM