Abstract

BRIEF NOTE ON PHARMACEUTICAL PRODUCT COMPLAINT HANDLING AND RECALL REGULATIONS OF USFDA

Setu Patel*, Darshil B. Shah and Dr. Dilip Maheshwari

ABSTRACT

Safety, efficacy and quality are the core responsible area for a Pharmaceutical manufacturer because they are directly dealing with the public health. A single mistake can have huge implications on the health system of a country example thalidomide tragedy. It is not important to establish a pharmaceutical production and just making down drugs day and night. It is the quality, safety and efficacy of the drug that really matters ultimately to the public. In United states their specific regulations for the recall and complaint handling which should be followed by the US government. In USFDA there are the three types of recall: FDA requested FDA Mandated and Voluntarily Recall system. These types of recall having different recall guideline. In complaint handling system they have noted down complaint as valid complaint and Invalid complaint and also they having different regulations mentioned in this article.

Keywords: Recall, Complaints handling, USFDA, Consumer product complaint system.