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8.3 Product Recalls

There is a system to recall from the market, promptly and effectively, products known or suspected to be defective. QP manager & Marketing manager have been designated for the execution and coordination of recalls, as well as sufficient staff to handle all aspects of the recalls with the appropriate degree of urgency.

There are established written procedures (retrieval of distribution data, notification of costumers, receipt/segregation/inspection of returned product, investigation/reporting of cause and reporting corrective action), which describe the sequence of actions to be followed, regularly are checked and up dated, for the organization of any intention recall activity. All competent authorities of our country are promptly informed of any intention to recall the product because it is, or is suspected of being, defective. In our country, recall decision is issued by M.O.H. The distribution records are readily available to distributor and they contain sufficient information on directly supplied customers to permit an effective recall. The effectiveness of the arrangements for recalls are evaluated from time to time. There is a segregate area in finished products warehouse for recalled products while their fate is decided.