At KorNutra, we have a step-by-step procedure for handling product recalls in gummy supplement manufacturing. It's built to protect consumer safety, meet regulatory requirements, and keep our brand's integrity intact. Our quality systems are designed to minimize risk, but if a recall is ever needed, we move fast and stay transparent.
Our Standard Recall Procedure
Our recall process follows a clear sequence.
- Identification and Investigation: Any potential issue — from internal QC, customer feedback, or regulatory notice — triggers an immediate investigation. Our recall team assembles to assess risk and find the root cause.
- Risk Classification: The team classifies the recall by health hazard (Class I, II, or III per FDA guidelines). That classification sets the urgency and scope.
- Decision and Strategy: Senior management, with QA and regulatory experts, makes the final call. Then we build an action plan: who to notify, how to communicate, and what to correct.
- Regulatory Notification: We promptly notify the FDA and other regulators, as required, and work with them through the process.
- Customer and Public Communication: We inform clients, distributors, and the public — with lot numbers, recall reasons, and return or disposal instructions.
- Product Retrieval and Segregation: We remove and isolate affected products from the supply chain so they can't reach anyone else.
- Corrective Actions and Prevention: We analyze what went wrong and put permanent fixes in place — whether in our processes, ingredient sourcing, or testing protocols.
- Effectiveness Checks and Closure: We verify the recall worked, then close it out with documentation and a final report.
Preventive Measures at KorNutra
Our primary goal is to prevent recalls through a robust quality framework:
- Supplier qualification and ingredient testing
- In-process quality checks at every stage
- Finished product testing for potency, purity, and stability
- Batch record documentation and traceability systems
- Regular facility audits and GMP training for staff
This approach means every gummy we manufacture hits the highest safety and quality standards. Our partners can count on that.