This guide is intended to help your company deal with FDA's regulatory inspections of food processing operations as well as inspections of warehouses, shippers and retail establishments. It is essential that all such establishments understand their rights and responsibilities with respect to FDA inspections, and have in place a detailed plan to prepare for and respond to such inspections.
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- INTRODUCTION
- I. FDA INSPECTION AUTHORITY
- A. FDCA § 704
- B. Scope of Inspection
- C. The Bioterrorism Act
- D. Refusal to Allow Inspection
- II. REASONS FOR AN FDA INSPECTION
- A. Routine Compliance Inspections
- B. Complaint Follow-up Inspections
- C. Recall Follow-up Inspections
- D. FDA Surveys
- E. FDA Food Security Surveillance Assignments
- F. Government-Wide Quality Assurance Program
- G. Office of Criminal Investigations
- III. PREPARING FOR AN FDA INSPECTION
- A. Company Inspection Policy
- B. Designation of Inspection Coordinator and Inspection Team
- C. Making Sure Your House Is In Order
- D. Mock Inspections
- E. Self Audits
- IV. THE INSPECTION
- A. Greeting of Inspector
- B. Pre-Inspection Conference
- C. Company Policies Affecting the Inspection
- 1. Affidavits and Statements
- 2. Photography
- 3. Questioning of Employees
- 4. Trade Secret/Confidential Information
- 5. Access to Company Records
- D. Correcting Deficiencies Uncovered During the Inspection
- E. Answering the Inspector’s Questions
- F. Samples
- G. Form FDA-483
- H. Post Inspection Conference with FDA
- V. POST-INSPECTION FOLLOWUP
- A. Post-Inspection Meeting of Inspection Team
- B. Reports of Sample Analyses
- C. Obtaining the Establishment Inspection Report (EIR)
- D. Response to Form FDA-483
- E. FDA Actions Following the Inspection
- VI. FDA ENFORCEMENT OPTIONS
- A. Warning Letter
- B. Recall Request
- C. Administrative Detention
- D. Seizure
- E. Injunction
- F. Criminal Prosecution
- G. States’ Enforcement Powers
- VII. SPECIAL TYPES OF INSPECTIONS
- A. Allergen Inspections
- B. Seafood Processor Inspections
- C. Juice Processor Inspections
- D. Low-Acid Canned Foods and Acidified Foods Inspections
- E. Dietary Supplement Inspections
- F. Infant Formula Inspections
- G. Cosmetics Inspections
- VIII. SPECIAL SETTINGS
- A. Retail Establishments
- B. Trains, Planes, Vehicles - Their Suppliers and Caterers
- C. Overseas Facilities
- IX. THE BIOTERRORISM ACT - FDA’S NEW RECORDS
- ACCESS AUTHORITY
- A. When FDA May Invoke § 414 Records Access
- B. How FDA May Obtain Records Access
- C. What Records FDA May Inspect and Copy
- D. Protection of Confidential and Trade Secret Information
- CONCLUSION
- RESOURCES
- EXHIBITS
- A. FDCA §§ 414 and 704 (21 U.S.C. §§ 350c and 374)
- B. Form FDA-482
- C. Form FDA-483
- D. Form FDA-484
- E. Establishment Inspection Report (EIR)
- F. Directory of FDA Office of Regulatory Affairs (ORA)
- G. Recent Statistics on FDA Food Inspections and Enforcement Actions
- ENDNOTES
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