FDA WARNING LETTER PROCESS: INSPECTION TO CLOSE-OUT LETTER IN THE PHARMACEUTICAL INDUSTRY
Warning letters are the official notification sent by the USFDA to the manufacturing unit head or the organizational point of contact to point out the disparities and infringement and request a response. In recent years, the pharmaceutical industry has faced increased scrutiny regarding data integrity, prompting regulatory bodies to issue numerous warning letters to companies that violate established standards. The Food and Drug Administration (FDA) is a federal agency that takes charge of inspection, focusing on quality and safety as its top priorities. The FDA controls the food items and pharmaceutical ingredients produced or imported into the US market. It evaluates its objectives by examining companies that sell goods in the US. It outlines effective production techniques for achieving high-quality final goods. Those who violate the guidelines will receive Warning Letters, and those who are unable to provide evidence to support the warning letter will have their marketing license revoked, based on the data gathered from inspections. This instills discipline in manufacturers and establishes a quality standard that must be met to remain competitive.