HANDLING OF MARKET COMPLAINTS AND RECALLS, REVIEW OF FDA-483 FORM

Abstract

In the pharmaceutical industry, any type of immediate response to the customer complaint can be critical because any product failure can be fatal situation for customer. Product complaint management is critical but essential component in the pharmaceutical industry from the point of view of regulatory and patient compliance. Once, the product get into market, the post marketing surveillance will start its role to monitor the adverse effect on population. The origin of complaint can be anything, like production, transportation and packing. This critical step needs uniform, single, and secured platform to manage product complaint right from initiation to the closure. Hence, the market complaints are handled with well defined procedure on higher priority. If the complaint is genuine, then a root cause analysis performed to rectify the problem and the product should be recalled from market if it is necessary. The main contributions of this paper will be to describe the concerns about the handling of market complaint, effective product recall and rule called as FDA - 483.