The Top 12 Questions You Can Expect During An FDA Inspection

FDA issues new guidance to inspectors.

On March 15, 2015, the FDA implemented a new medical gas inspection guidance document for inspectors called Compliance Program Guidance Manual, Compressed Medical Gases. In addition, the FDA trained state Boards of Pharmacy on how to use this new manual to inspect a medical gas facility. While the FDA’s interpretation of Current Good Manufacturing Practices is still evolving, it is useful to know the script of the inspectors before they arrive at your plants.

The agency has established a risk-based system for determining which facilities to visit and how comprehensive the inspection needs to be. There are two categories of inspections: Full and Abbreviated.

  • The Full Inspection looks at the “Quality System,” “Laboratory System” and at least two other systems. Other quality systems include: Facilities and Equipment System, Materials System, Production System and Packaging and Labeling System.
  • The Abbreviated Inspection includes the “Quality System” and at least one other system.

The Abbreviated inspection contains at least the following 12 key questions from the other systems:

  1. Does the firm adequately test both incoming components and finished products?
  2. Has the analytical equipment been appropriately calibrated?
  3. Have alternative test methods been validated against official compendial test procedures?
  4. Is equipment qualified prior to first use (i.e., stainless steel hoses, large cryogenic containers)?
  5. Are personnel (including filling personnel and delivery staff) adequately trained to do their jobs, including training in CGMPs?
  6. Are there standard operating procedures for manufacturing, processing and testing, and are they followed?
  7. Do production records document all significant steps?
  8. Are prefill checks conducted (especially for new cylinders)? (See note below)
  9. Is equipment checked for continued suitability after cleaning, repairs, refurbishment, etc.?
  10. Are labels controlled (i.e., reconciliation of labels and no observed mislabeling)?
  11. Are labels accurate and do they include adequate instructions for use? (See note below)
  12. Are control mechanisms used to prevent contamination or mix-ups (e.g., are operations performed in specifically defined areas)?

For GAWDA members, a free Excel spreadsheet has been developed that includes these 12 questions and the other 94 questions from the guidance. Also included are long-standing CGMP best practices. This is actually the framework used when we conduct mock audits. The spreadsheet automatically scores your compliance for ongoing comparisons and control.

Contact tom@asteriskllc.com if you would like to download the latest mock audit spreadsheet with the key questions from the FDA inspectional guidance. We can also send you the full text of the FDA Compliance Program Guidance Manual, Compressed Medical Gases (7356.002E).

Gases and Welding Distributors Association
Thomas Badstubner Meet the Author
GAWDA’s FDA & Medical Gases Consultant Thomas L. Badstubner is president of AsteRisk LLC in Lewisville, Texas. Members can reach him at 508-883-0927 and tom@asteriskllc.com.