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FDA Inspections

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.

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FDA Inspections

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  1. FDA Inspections Stephen Joseph Joy’s Quality Management Systems Stephen@joysqms.com 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 110 ---- 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

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