Post Market Compliance
POST-MARKET SURVEILLANCE & RECALL COMPLIANCE POLICY
Distributors and Resellers
PURPOSE
This notice outlines the post-market surveillance and recall responsibilities associated with the cosmetic products (“Products”) supplied under all Sales Orders.
By accepting the delivery of the Products under a Sales Order, the seller (Distributor and/or Reseller, as applicable) acknowledges receipt of this Post-Market Surveillance & Recall Compliance Notice with OFRA Cosmetics LLC (the “Manufacturer”) and agrees to comply with the responsibilities outlined herein, in accordance with ISO 22716 (Good Manufacturing Practices for Cosmetics) and the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
No further signatures are required; acceptance of the Sales Order implies acceptance of this Notice.
POST-MARKET SURVEILLANCE RESPONSIBILITIES
Adverse Event & Complaint Reporting
• The Distributor must have a system in place to monitor and record consumer complaints, including potential adverse events related to the Products.
• If the Distributor becomes aware of any serious adverse event, it must notify the Manufacturer as soon as possible, no later than 5 business days, providing all relevant details, so that the Manufacturer can investigate the complaint and comply with FDA and MoCRA requirements.
• The Distributor must retain complaints and adverse event records for at least six (6) years.
Product Monitoring & Compliance
• The Distributor shall ensure that Products are stored, handled, and distributed in compliance with ISO 22716 guidelines to maintain safety and integrity.
• If a regulatory authority requests information or conducts an inspection regarding the Products, the Distributor must notify the Manufacturer immediately.
REFERENCES
• ISO 22716 Section 14.3 Product Recall Procedures
CUSTOMER DISTRIBUTION RECORDS AND RECALL
Record-Keeping
4.1.1 The Distributor must document, retain, and provide all relevant customer distribution records to the Manufacturer and all recall-related actions, if any, for a minimum of six (6) years.
Recall Execution
4.2.1 If a recall is required due to safety concerns, regulatory non-compliance, or product defects, the Distributor must:
• Cease sales of affected Products immediately.
• Notify retailers and customers in the supply chain.
• Cooperate fully with the Manufacturer and regulatory authorities to execute the recall effectively.
The Manufacturer will provide recall instructions and report the recall to the FDA or relevant regulatory body, as required.
LIABILITY & INDEMNIFICATION
• The Manufacturer guarantees that the Products supplied under all Sales Orders comply with MoCRA and ISO 22716 at the time of shipment.
• The Distributor is responsible for ensuring Products are marketed and sold in accordance with local regulations.
• The Distributor shall indemnify the Manufacturer against any claims, penalties, or damages resulting from improper storage, handling, or marketing of the Products.
END OF DOCUMENT
REVISION HISTORY
Rev. 01
Effective Date: June 10, 2025
Description of Change: Initial Release
Originator: M Asprino
Release Authorization: C Leon