Falcon Stars Group Ltd | FSG-POL-PSR | Version 1.0
Effective: 2 October 2026 | Next review: 2 October 2027
Policy owner: Managing Director
Falcon Stars Group Ltd places product safety and traceability at the centre of its supply activities. The Managing Director coordinates safety concerns, containment and recall support within the company's applicable role as supplier, importer or distributor. This policy does not replace the duties of manufacturers, UK Responsible Persons or other regulated parties.
Contact adnan@falconstars.co.uk promptly with the product, order, batch or serial reference, the nature of the concern and affected quantities or locations where known. Report suspected serious incidents, sterility or labelling failures, counterfeit products and field safety notices without waiting for a full investigation. Avoid unnecessary patient-identifying details. In an emergency, seek appropriate emergency or clinical assistance.
We will record the concern, assess urgency and identify potentially affected products and customers. Where necessary, supply will be stopped and affected stock placed on hold or segregated by the party holding it. Relevant records and evidence must be preserved. Potentially unsafe items must not be returned to supply without a documented, authorised decision based on appropriate evidence.
We will promptly contact the manufacturer, UK Responsible Person or other relevant operator and cooperate with the competent authority as required. Applicable reporting duties and timescales will be assessed for the particular incident and our legal role. Urgent escalation must not be delayed while root cause is being established. We will relay relevant safety instructions to affected customers and providers, seek confirmation of required actions and maintain traceable communication records.
Where a recall, withdrawal or other field action is required, we will support identification, communication, recovery, reconciliation and documented disposition of affected products. We will follow the agreed safety instructions and coordinate with the responsible parties. A return, replacement or destruction decision must consider safety, traceability and legal requirements; it must not be improvised or treated as proof that an incident is closed.
We will review the extent and cause of the issue, record corrective actions and check their effectiveness before closing the matter. Supplier performance, risks and relevant controls will be reviewed. Storage or logistics partners, when appointed, must support agreed traceability and safety-action requirements.
Controlled procedures: PR-007 Nonconforming Outputs, Complaints and CAPA; PR-004 Supplier and Outsourced Provider Control.
Reviewed at least annually and following significant changes or relevant incidents. Initial issue: Version 1.0, 2 October 2026.
Approved on behalf of Falcon Stars Group Ltd
Adnan Aslam, Managing Director
2 October 2026. The signed policy is available in the PDF above.