1. FDA Inspections Stephen Joseph Joy’s Quality Management Systems
September 24, 2015
ASQ QLN FSMA Workshop

2. What to Expect FDA Inspection Guidance Docs and Manuals
Investigations Operations Manual (IOM) – Chapter 5
FDA Food Compliance Program

3. Which Regulations Apply?
FDA Regulates Good Manufacturing Practices for Multiple Industries that manufacture, package, label, and hold:
Pharmaceuticals – 21 CFR Part 210/211
Dietary Supplements – 21 CFR Part 111
Foods – 21 CFR Part  FSMA - 21 CFR Part 117
Cosmetics – not finalized
Know which Regulations apply to your operations!

4. FDA Inspectional Focus
FOOD FOCUS:
Foodborne Biological Hazards
Chemical Contamination
Food and Color Additives
*Note: Investigators are directed to take samples for analytical testing of suspected materials.

5. Prepare for Inspection
Know and follow your company policies and procedures.
Management’s Role - know responsibilities to ensure compliance.
Employees must be trained in job duties and applicable cGMPs.

6. Preparing for an FDA Inspection
Documented Training
cGMPs, SOPs, and Company Policies.
Designated Audit Team
Usually the lead person for accompanying the inspector is from QA . Management should participate in the opening meeting and the closing with FDA.
Subject Matter Experts for answering questions pertaining to specific areas.
Persons for retrieving records and documenting communications.
Practice these roles! Mock Audit!

7. Other Considerations Other Business Models
OLD’s and Distribution Warehouses are required to comply with cGMPs.
OLDs will be inspected by FDA and are ultimately responsible for compliance their products.

8. Don’t Be Caught Off-Guard
Be Prepared for FDA’s Arrival
Be Proactive, Make Corrections
Information is out there!
Unsure? - Seek Help