Food Safety Plans
Compliant Food Safety Plans with Register FDA
Overview of Food Safety Plans
Under the FDA's Preventive Controls Rule, food manufacturers are required to identify potential food safety hazards and minimize their risks. This involves the implementation, monitoring, and verification of control measures, along with necessary corrective actions to address any deviations or problems. Additionally, a comprehensive Food Safety plan should include a Recall plan for dealing with significant hazards.
Most food facilities registered with the U.S. Food and Drug Administration must develop and execute Food Safety plans that adhere to the FDA’s Preventive Controls regulatory guidelines. Notably, other food safety systems like Hazard Analysis and Critical Control Points (HACCP) may not fulfill the requirements of the Preventive Controls.
To comply, Food Safety plans must be written, enacted, and supervised by a Preventive Controls Qualified Individual (PCQI). Facilities processing foods for U.S. consumption without an approved Food Safety plan risk being marked as noncompliant.
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Frequently Asked Questions
Answers To Commonly Asked Questions
"Does possessing a food facility registration authorize me to sell my products in the U.S.?"
Simply being registered does not imply FDA approval of your products, nor does it endorse them.
"Is it mandatory for foreign food facilities to appoint a U.S. Agent for registration purposes?"
Yes, foreign facilities must designate a U.S. Agent to facilitate communication with the FDA.
"What duties does a U.S. Agent for FDA food facility registration have?"
The U.S. Agent must reside in the United States and aid in both communication with the FDA and the coordination of inspections.
"Can I complete my food facility registration initially and appoint a U.S. Agent afterward?"
No, registration activation necessitates having a U.S. Agent from the outset.
"Is it possible to replace my U.S. Agent after the food facility registration?"
Yes, you are permitted to appoint a different U.S. Agent after registration.
"What options exist for a foreign company without a U.S. representative to act as a U.S. Agent?"
A third-party service, like FDA Specialist, can be employed to fulfill the role of U.S. Agent.
"What information is required for obtaining a U.S. FDA food facility registration?"
You need to provide specific details about your company and the types of food it manages. A DUNS number is also necessary for registration.
"If our manufacturer is registered with the FDA, does it mean their products are approved for sale in the U.S.?"
No, having a registration does not equate to FDA approval of the products.
"Can the U.S. Agent for my food facility registration be based outside the United States?"
No, the U.S. Agent needs to be based within the United States.
"Will the FDA accept a food facility registration from a non-U.S. government?"
No, to market foods in the U.S., facilities must be registered directly with the U.S. FDA.
