The U.S. Food and Drug Administration (FDA) conducts inspections and assessments of regulated domestic and foreign facilities or establishments, to determine firms compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic Act. This typically involves an investigator visiting a firm’s location.
FDA has authority to request inspections in foreign countries. If foreign firms refuse to permit such inspection and there is the appearance of a violation, FDA has the option of not granting approval of the application and refusing entry of those products when offered for import.
International inspections are usually preannounced. A request containing the proposed inspection dates is made to the foreign manufacturer either by direct contact or through an U.S. Agent.
FDA maintains a roster of investigators or analysts who have been recommended by district management to have demonstrated experience and special expertise in one or more of the following program areas:
▪ Biologics
▪ Bioresearch Monitoring
▪ Biotechnology
▪ Computer Software Development
▪ Drugs (Human and Veterinary)
▪ Food, Acidified Foods (AF) or Low-acid Canned Foods (LACF)
▪ Medical Devices
▪ Sterile products
FDA Food Safety Modernization Act’s (FSMA) Intentional Adulteration (IA) rule is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide scale public health harm. Such acts, while not likely to occur, could cause illness, death, economic disruption of the food supply absent mitigation strategies.
Food facilities covered by the rule are required to develop and implement a food defense plan that identifies vulnerabilities and puts in place mitigation strategies to address those vulnerabilities. Rather than targeting specific foods or hazards, this rule requires mitigation (risk-reducing) strategies for processes in certain registered food facilities. A reanalysis is required every three years or when certain criteria are met, including mitigation strategies that are determined to be improperly implemented.
Food defense plans (FDPs) may include sensitive information and it is the facility’s responsibility to ensure files are saved and stored in a secure location.
The Food Defense Plan Builder (FDPB) is a user-friendly tool, standalone desktop application, designed to help owners and operators of food companies in the development of a food defense plan that is specific to their facilities, and guides the user through the following sections:
▪ Facility Information.
▪ Product/Process Descriptions.
▪ Vulnerability Assessments.
▪ Mitigation Strategies.
▪ Food Defense Monitoring Procedures.
▪ Food Defense Corrective Actions Procedures.
▪ Food Defense Verification Procedures.
▪ Supporting Documents.
▪ Food Defense Plan Signatures.
▪ Very small business.
▪ The holding of food, except the holding of food in liquid storage tanks.
▪ The packing, re-packing, labeling or re-labeling of food where the container that directly contacts the food remains intact.
▪ Activities that fall within the definition of “farm”.
▪ Manufacturing, processing, packing, or holding of food for animals.
▪ Alcoholic beverages under certain conditions.
▪ On-farm manufacturing, processing, packing, or holding by a small or very small business of certain foods identified as having low-risk production practices. The exemption applies if such activities are the only activities conducted by the business subject to the rule. These foods include certain types of eggs, and certain types of game meats.
You just received an email from the FDA indicating the agency’s intention to inspect your facility or establishment. Then, what?
Contact ITB HOLDINGS LLC the same day, 24/7, not weeks later. Forward a copy of the message.
Our service below will get you started.
▪ Responding to FDA Request
▪ Inspection Preparation
▪ Inspection Follow Up
