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

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

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 110 ---- FSMA - 21 CFR Part 117 Cosmetics – not finalized Know which Regulations apply to your operations!

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.

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.

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!

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.

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