Adverse Event & Consumer Safety Policy

Description

Adverse Event & Consumer Safety Policy

Official Regulatory Protocol | O.L.C. Cosmetics & SkinCare Manufacturing

This policy establishes the official procedures for the prevention, monitoring, and resolution of adverse events. As a licensed manufacturer, we prioritize consumer safety through a rigorous Post-Marketing Surveillance (PMS) system, ensuring every product meets the safety standards set by the FDA Philippines.

Step 1: Prevention and Mandatory Precautions

Every product manufactured by our facility includes specific precautions and directions for use clearly printed on its labeling. We require all consumers to read these instructions thoroughly before the first application. A mandatory 24-hour patch test on a clean area of the inner forearm is required for every new product to identify individual skin sensitivities. The company cannot be held liable for adverse reactions arising from a failure to follow these established safety guidelines or for the misuse of the product outside its intended purpose.

Step 2: Adverse Event Reporting Procedure
In the event of an unintended reaction, such as localized redness, itching, burning, or swelling, the consumer must immediately cease use of the product and rinse the affected area with cool water. It is a requirement of this policy that the event be reported to our Quality Assurance department within forty-eight (48) hours of the occurrence. To ensure a valid investigation, the reporter must provide the specific batch or lot number found on the packaging, clear visual documentation (photographs) of the reaction, and a brief description of the application method used.

Step 3: Internal Technical Investigation 
Upon receipt of a valid report, our technical team will initiate a formal Root Cause Analysis (RCA) within our laboratory. This process includes pulling the “Retain Sample” from the specific production batch kept in our climate-controlled storage to re-verify its chemical stability and microbiological safety. We also conduct a comprehensive audit of the original manufacturing logs and raw material Certificates of Analysis (COA) to confirm that the batch met all internal quality specifications and regulatory requirements before its release to the market.

Step 4: Regulatory Compliance and FDA Reporting
We maintain strict adherence to the reporting timelines and protocols mandated by the FDA Philippines Center for Cosmetics and Household/Urban Hazardous Substances Regulation (CCHUHSR). Any event classified as a Serious Adverse Event (SAE)—defined as a reaction resulting in hospitalization, persistent disability, or significant disfigurement—will be reported to the FDA within seven (7) calendar days of our notification. All documentation related to these events, including investigation results and causality assessments, is stored within our Product Information File (PIF) and remains available for government inspection for a minimum of three (3) years.

Step 5: Resolution and Corrective Action
Following a completed investigation, if a product defect or formulation non-compliance is confirmed, we will provide a resolution in accordance with the Consumer Act of the Philippines (R.A. 7394). This typically involves a full refund or a product replacement to ensure the consumer is appropriately compensated. Furthermore, the company will implement immediate Corrective and Preventive Actions (CAPA), which may include formula optimization or batch recalls, to ensure that our commitment to the safety of the Filipino beauty community remains uncompromised.