Product Recall Policy

Gloved hands scanning an unbranded bottle beside a batch record sheet

PRODUCT SAFETY

Recall and Traceability Policy

If a batch ever needs to be withdrawn, the important thing is that we can identify it, notify the right people quickly and account for where it went. This page sets out how that works.

  • Every batch traceable by lot number from raw material to shipment
  • Documented notification route to the customer of record
  • Corrective action recorded and reviewed after any withdrawal

How we trace a batch, decide whether to recall, notify the people who need to know, and close the issue out. Because the time to read a recall procedure is not during a recall.

Scope

This procedure covers any finished product manufactured or packed by Huibojian (Zhengzhou) Health Technology Co., Ltd. that has left our control and may present a food-safety, quality or labelling risk. It applies to a full recall, a partial recall and a market withdrawal — the three are different in law and different in urgency, and we say which one applies when a case is opened.

Traceability

Every batch is traceable one step back and one step forward. For each release batch we retain:

  • Batch number and production date, linked to the production record
  • All raw material lot numbers consumed in the batch, with supplier and incoming-inspection records
  • Finished-goods test results and the released Certificate of Analysis
  • Packaging lot and artwork version used
  • Dispatch records: which customer received how many units, under which invoice and shipment

These records are retained for a minimum of two years beyond the stated shelf life, or longer where the destination market requires it.

What Triggers a Recall or Withdrawal

TriggerTypical response
Confirmed pathogen or foreign-body contaminationRecall
Out-of-specification assay or a label that misstates an activeRecall or withdrawal, depending on the risk assessment
Allergen not declared on the labelRecall
Undeclared ingredient that is a regulated allergen or prohibited substanceRecall
Packaging defect affecting product integrityWithdrawal or recall, depending on the defect
Regulatory action in a destination marketAction as directed by the authority

A missing Certificate of Analysis or a documentation error is not by itself a recall trigger, but it is a corrective-action trigger and is handled under the same procedure.

Decision and Roles

  • Quality Manager — assesses the risk, opens the case, drafts the technical statement, and owns the record.
  • General Manager — authorises the recall, and is the only person who may close it.
  • Sales and customer contact — notifies affected buyers and coordinates stock recovery.
  • Production — quarantines remaining stock of the affected batch and traces the production record.

A recall decision does not wait for complete information. We act on the precautionary principle when the risk to a consumer is plausible, and we correct the scope later if the evidence allows.

Notification

TimelineAction
Within 24 hours of a confirmed triggerAffected buyers notified by email and telephone, with the batch number, the nature of the issue and the action required
Within 48 hoursWritten recall notice issued, including recovery instructions and a contact for questions
Within 72 hoursRegulatory authority notified where the destination market requires it
OngoingRecovery status reported to the affected buyers until the recall is closed

The written notice states plainly what is wrong, which batch is affected, what the buyer should do with held stock, and what happens to stock already sold through to consumers.

Recovery and Disposition

Recovered stock is quarantined and clearly labelled as held. It is not returned to saleable inventory, reworked into another batch, or disposed of without a recorded decision. Disposition is documented, and where the product is destroyed, this is done under supervision with a record kept.

Costs and Remedy

Where a recall is caused by a defect in our manufacturing, our packaging or our documentation, we bear the cost of recovery and replacement. Where it is caused by a specification, artwork or instruction supplied by the buyer, responsibility is apportioned accordingly. We discuss the position openly as soon as the cause is understood, rather than waiting for the recall to close.

Root Cause and Closure

Every recall is followed by a root-cause investigation and a corrective and preventive action plan. The recall is not closed until the corrective action is verified as effective. Buyers affected by a recall receive the root-cause summary on request.

Drills

We run at least one traceability exercise a year, in which a batch is chosen at random and the full chain — raw materials to dispatched customers — is traced and timed. The result is recorded.

Related Pages

The policies and systems behind how we run the business.

Need This Procedure for Your Due Diligence?

If your compliance process requires a documented recall procedure, or a signed version for a supplier file, tell us and we will provide it in the format you need.

  • Available as a signed PDF
  • Traceability drill records available under NDA
  • We can complete your supplier quality questionnaire

Tell us what you want to build — get a firm quote within 48 hours.

A real person reviews every enquiry — not a generic auto-reply. Only four fields are required (marked *); everything else just helps us quote faster.

1. Your Product

This field is required.
Dosage Form
Formula Status
This field is required.

2. Volume, Budget & Timeline

Estimated Order Quantity
Budget for This Project
This field is required.
When Do You Want to Start Production?
Target Market

3. Where to Send Your Quote

This field is required.
This field is required.
This field is required.
This field is required.

Have a spec sheet, formula or competitor label?

Email it to sales@huibojian.com or WhatsApp +86 155 3810 3310 and quote your name — we will match it to this enquiry. NDA available on request.
We reply within one business day. A real person, not a generic auto-reply.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Get a Free Quote
×Certificate enlarged view
Chat on WhatsApp
Get a Free Quote