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Recall And Complaints Procedure for Product

Recall and complaints both are different things that are used for marketed products. Recall means a company’s removal and correction of a marketed product that the FDA considers to be in violation of GMP. The Recall does not include market withdraws.

Whereas for product Complaint is not good things. It shows customer dissatisfaction with the manufacturer’s products.

Product complaint Principle:

“All complaints and different information regarding the probably defective product should be reviewed per written procedures.”


  • To identify the key problems in product complaint and recall handling
  • To understand the particular necessities for organization, procedures, and resources
  • To understand and develop actions to resolve current problems applicable to you

Complaints Handling Principle:

All complaints and different info regarding the probably defective product should be carefully reviewed per written procedures Handled positively thoroughly reviewed.

Must be seen as necessary work Managed by a senior person thorough investigation of the cause is crucial.

Enable potential production defects to be remedied before they lead to a recall.

Necessary actions to be taken, even a recall call and complaints.

Complaints Procedure – I

  • Must be a Designated accountable person or Maybe authorized trained person
  • If not, should advise an authorized person of results.
  • Sufficient support staff
  • Access to records
  • Written procedure describing the action to be taken
  • Acknowledge and answer complainant inside an affordable reasonable
  • Record has written and verbal comments.

Complaints Procedure – II

  • Investigate and review
  • QA review complained
  • Appropriate follow-up actions
  • Review of trends

Records of details Recall and complaint Investigation:

  • Name of product
  • Name of the active substance, if applicable.
  • Strength and doses form
  • Manufacturing or packing Batch no.
  • Name of complainant and nature of the Complaint
  • Records, retention sample (control sample) investigated, different batches reviewed and interviewed of the involved person.
  • Result of investigation: “Justified” or “Not justified.”
  • If “justified”, actions are taken to stop reoccurrence.
  • Sign-off upon completion

Report No.

Date Received

Product Name

Receive By

Product Lot No.

Start Date of Investigation

End Date of Investigation

The decision from a complaint Investigation:

Justified Complaint 

  • Actions to stop reoccurrence
  • Ongoing observation of processing method
  • Recall product may be needed

Non- justified Complaint

  • Advise client of findings
  • Appropriate selling response

Other problems related to Recall and complaints:

  • Regular review of trends needed
    • Reoccurring issues
    • Potential Recall or withdrawal
  • Inform competent authority of significant quality issues

Classification of Defects

If the Complaint is even, then there has been a failure of the standard quality system.

Once the defect has been known, a company ought to be handling it in an associated manner, even recall. Defects include:

Critical defects

Major defects

Other defects

Read about Types of Defects

Reasons for Recall:

  • A Complaints from the customers
  • Detection of GMP failure when products reach the market
  • The result from the continued stability testing
  • Request by the national inspection authorities
  • Result of associate review
  • Known counterfeiting or change of state
  • Reporting of any adverse reaction

Detection of GMP failure:

Blister with empty or broken tablets in a blister pack.

Product Recall Principle:

“There ought to be a system to recall from the market promptly and effectively, product renowned or suspected to be defective.”

Recall Definition:

  • Removal from the market of fixed batches of a product
  • Maybe one batch or all batches of product

Designated accountable Recall Person:

  • Maybe the well-trained person
  • If not, should advise the well-trained person of results
  • Sufficient support employees for the urgency of the Recall
  • Independent of sales and selling
  • Access to records

SOP for Recall:

There shall be an Established, authorized procedure for taken action. It should be checked and updated Capable of fast operation to hospital and pharmacy level Communication idea to national authorities and internationally.

Distribution Records:

There shall be a well-trained person for recall functions. Distribution records shall be Accurate and must-have information of Wholesalers, Direct customers, Batch numbers, and Quantities.

Written report and reconciliation

  • Record progress as the procedure followed
  • Reconcile delivered with the recovered product
  • Issue final report
  • Effectiveness of procedures checked
  • Test effectiveness from time to time
  • Secure divided storage of products that are returned.

Possible problems during Recall:

  • No response to even complaints
  • Response to unreasonable complaints
  • Failure to recall
  • Failure to correct frequent complaints
  • No resources to research
  • No senior management support
  • Senior management interference
  • No distribution information/batch records
  • No access to records
  • Inability to contact government throughout holidays/weekends
  • Disagreement on the severity of the defect
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