Report product defects
Find out about information required and guidelines to report product defects to HSA.
Last updated 13 March 2026
Types of defect to report
The company needs to report critical or non-critical defects of:
Affected batches which have been imported for supply or supplied in Singapore.
Affected batches which the company intends to import into Singapore for supply.
This include defects resulting from manufacturing deviations or non-compliances to Good Manufacturing Practice (GMP) at a manufacturing plant which may be in Singapore or overseas.
Information to be included in the product defect reports
The initial report of product defect should contain as much details as available, but reporting should not be delayed due to the time needed to gather the full information. The minimum information required for the submission of an initial report of product defect is:
Product information.
Description of defect.
Number of the product(s) or batch(es) affected.
Date of occurrence.
Expiry date of affected batch(es).
Date of last distribution of the affected batch(es) to the market.
An identifiable reporter.
Following the initial report, the company will need to submit the investigation report, health hazard assessment, and corrective and preventive actions (CAPA) plan to HSA.
The follow-up investigation and risk assessment report should include the following (but not limited to):
Full description of the defect.
Explain how the defect occurred and the date of occurrence.
Explain how the defect was discovered and the date it was discovered.
Evaluation of samples of the defective product obtained from the complainant (if any).
Local distribution records of affected batches.
Overseas distribution list of affected batches exported from Singapore.
Indicate whether the product was sold under tender contract or pending tender consideration.
Review of batch records and any change controls or deviations associated with the batches.
Review of previous complaints, quality defect reports and relevant information for any indication of recurring problems; whether other similar defect had occurred locally or globally.
Indicate if the defect affects all batches or only selected batches. Review of whether other batches and, if other products could be affected. Explain why the defect affects only selected batches.
List down the regulatory actions taken or to be taken by other regulatory authority or by the company.
Identify possible root causes of the defect.
Health hazard assessment on the potential short-term and long-term consequence of the defect to intended users.
Certificate of Analysis of the affected batch(es).
Examine and test reference and/or retention samples if needed.
Assessment of the appropriate market actions necessary for the affected stocks, including whether it is necessary to quarantine or recall any existing stocks.
Indicate whether there could be a supply shortage as a result of the defect or market action.
Provide description of the Corrective and Preventive Actions (CAPAs) taken or to be taken to prevent a similar defect from recurring.
When to report
Timelines for reporting product defects to HSA
Classification of product defect | When to report upon becoming aware of the defect |
|---|---|
Critical defects | Within 48 hours (excluding Sundays and public holidays) |
Non-critical defects | Within 15 calendar days |
For critical defects that pose a risk to the public, prompt measures must be taken to minimise the risk (including market actions) even if they need to be taken during non-working hours.
How to report
The company can use the Product Defect Reporting Form to report product defect to HSA.
The completed product defect reporting form and any other accompanying documents must be submitted within stipulated timelines to:
Vigilance and Compliance Branch
Email: HSA_productdefect@hsa.gov.sg
For reporting of product defects in products in clinical trials, please submit reports to:
Innovation Office & Clinical Trials Branch
Email: HSA_CT@hsa.gov.sg
What happens after a defect is reported
Upon receipt of the product defect report, HSA will review the information provided in the report and may request for further information required for assessment. Depending on the potential risk to the intended users or to public health, HSA may require additional risk control measures, such as:
A product recall.
Issuance of a Dear Purchaser Letter
Issuance of Dear Healthcare Professional Letter.
Issuance of a press release.
Suspension or cancellation of the product registration.