If Field Safety Corrective Action is issued by the manufacture on specific serial or lot numbers, and these products with these numbers have not been imported into the KSA or put on the market, should we inform the SFDA about this Field Safety Corrective Action?
Question
If Field Safety Corrective Action is issued by the manufacture on specific serial or lot numbers, and these products with these numbers have not been imported into the KSA or put on the market, should we inform the SFDA about this Field Safety Corrective Action?
Answer
No, KSA is considered not affected in this case. But in case SFDA inquires about these products, you must provide a statement confirming KSA is Not Affected by Field Safety Corrective Action.
