Importing: What Happens If Something Goes Wrong?
Importing: What Happens If Something Goes Wrong? By Nick Lahey, EAS Consulting Group Independent Consultant The U.S Food and Drug Administration (FDA) works hand and hand with U.S. Customs and Border Protection (CBP) with the import process of FDA-regulated...
What Not To Feed Your Dog
Originally posted on American Council on Science and Health By Jane Caldwell, Ph.D. We love our dogs and puppies. They are faithful, non-judgmental companions who delight in our presence. Many pet owners return this affection by feeding them treats. But some human...Establishing an Effective Environmental Monitoring Program
Prevention of product contamination through an Environmental Monitoring Program is a requirement across FDA regulated industries. This ensures product safety and reduces the likelihood of an adverse event(s) for the consumer. An established EMP is required by FDA as part of a Good Manufacturing Practice (GMP) quality system.
Responding to an FDA Form 483 – Tips for Compliance Success
By Amy Scalin, M.S. Hearing from FDA often means one thing: The Agency has found issues with your operations that require a swift response and corrective actions. FDA uses numerous tools to notify firms of regulatory compliance enforcement. Most commonly, a firm will...