As recent headlines demonstrate, non-compliance with US Food & Drug Administration US FDA laws and regulations could cost your firm millions. In addition to significant revenue losses, violative US FDA inspections may also lead to injunctions, consent decrees, warning letters, FDA 483 's Notice of Inspectional Observations, product non-approvals, import detentions, recalls, criminal investigations and prosecutions, seizures, compliance problems, FDA compliance meetings, and monetary penalties.

According to the U.S. Food and Drug Administration Report entitled FDA's Growing Responsibilities for the Year 2002 and Beyond, the FDA ensures the safety and in most cases the quality and effectiveness of a trillion dollars' worth of products that constitute nearly one-fourth of the total consumer expenditures of US citizens. FDA's mission is to promote and protect the public health by helping safe and effective products reach the market in a timely way and monitoring products for continued safety after they are in use. One way that the FDA fulfills it's mission is through inspections of developers, manufacturers, laboratories, and distributors of regulated products. Inspections ensure a firm is compliant with US Food and Drug Administration Laws and Regulations.

So, it is criticial that your manufacturer, distributor, relabeler, or repackager properly plan, coordinate, host, and follow-up to FDA inspections. It is also critical that your company remains knowledgeable and in compliance with US Food and Drug Administration ( FDA) laws, regulations, and guidelines such as Current Good Manufacturing Practices (cGMP's), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), QSR, Federal Food, Drug, and Cosmetic Act (FD&C Act) United States Code (U.S.C.) Title 21, Chapter 9, Amendments to the FD&C Act, Code of Federal Regulations (CFR), Nutrition Labeling and Education Act of 1990 (NLEA), Animal Drug User Fee Act of 2003, Bioterrorism Act of 2002, Project Bioshield Act of 2004,Lead-Based Paint Poisoing Prevention Act, Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994, Food Quality Protection Act of 1996 , Best Pharmaceuticals for Children Act , Food Allergen Labeling and Consumer Protection Act of 2004, Prescription Drug User Fee Act (PDUFA) of 1992, Dietary Supplement Health and Education Act of 1994, Generic Animal Drug and Patent Term Restoration Act of 1988, Prescription Drug Marketing Act of 1987, Clinical Laboratory Improvement Amendments, Animal Drug Availability Act of 1996, Pediatric Research Equity Act of 2003, Medical Device User Fee
and Modernization Act of 2002 , Dietary Supplement Health and Education Act of 1994, Medical Device User Fee and Modernization Act (MDUFMA) of 2002, etc..

FDA inspections .com was developed by a former award-winning US Food and Drug Administration US FDA Consumer Safety Officer to provide educational, training and informational FDA inspectional and related resources to assist pharmaceuticals, medical devices, in-vitro diagnostics, biologics, nutraceutical, biotechnology, biopharmaceuticals, animal drug, food, and cosmetics manufacturers, distributors, relabelers, repackagers, and distributors with their US FDA Inspections. . If you have any questions, please email us or call 403-770-1994.

• How to prepare and plan for an FDA inspection
• How to train your employees and management for an FDA inspection
• What can you expect from an FDA inspection
• Who will be inspecting our company
• How does the FDA train the people inspecting our company
• What guidance and procedures do the people inspecting us follow
• What types of companies does the FDA inspection
• What laws and regulations form the basis of an FDA inspection
• What laws and regulations will our company be inspected to
• What are the different types of inspections
• What are the stages of an inspection
• Will I be notified of an inspection
• Do I have to pay for an inspection
• What are systems inspections
• What are the first stages of an FDA inspection
• Who should be present during an FDA inspection
• How should people behave during an FDA inspection
• Should our company have an SOP for FDA inspection
• Can I limit the scope of inspection
• Is there anything the FDA is not eligible to see
• What areas will the FDA inspect
• What is the FDA's Inspectional Approach
• What do they look for during a walkthrough
• Who are in Team Inspections
• What records will the FDA inspect
• How does FDA document it's findings or inspectional observations
• How does FDA have to support it's findings or inspectional observations
• What information can the FDA request during an inspection
• What areas can the FDA request to see during an inspection
• Who can the FDA talk to during an inspection
• What inspectional tools and investigative techniquest do the FDA use
• How do they inspect different areas of our facility Are photographs, recording or sampling allowed during inspections
• What is on an FDA-483
• What is considered an FDA observation
• What is considered adulteration of product
• Can the FDA require a recall
• When can the FDA detain my products for import/export
• What should we do if the FDA finds an observation or deviation during an inspection
• What does the FDA do after an Inspection
• What should our company do after an Inspection

CSO
Consumer Safety Officer

EIR
Establishment Inspection Report

GWQAP
Government Wide Quality Assurance Program

NDA
New Drug Application

PAI
Pre-Approval Inspection

CDER
Center for Drug Evaluation and Research

CARS
Compliance Achievement Reporting System

CFSAN
Center for Food Safety and Nutrition

ORA
Office of Requlatory Affairs

CBER
Center for Biologices Evaluation and Research

CVM
Center for Veterinary Medicine

CFR
Code of Federal Regulations

CDRH
Center for Devices and Radiological Health

QSIT
Quality Systems Inspection Techniques

CI
Criminal Investigators

DOJ
Department of Justice

QSIT
Quality Systems Inspection Techniques

ADRS
Adverse Drug Reporting System