Wednesday, February 4, 2015

Major USFDA warning Letters observation from 2000

The United States Food and Drug Administration (FDA) defines a Warning Letter as

"...a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes. Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency’s principal means of achieving prompt voluntary compliance with the Act.

Featured Post

Complication in Pharma industry with stability issue and salary expectation in Indian scenario

Now a days the pattern of interview is very interesting in pharma industry. The main argument comes with following points, Exp...