The Business Owner’s FDA Checklist

Eight quick action items to prepare for an investigation

Most FDA inspections are fairly routine, and while we are occasionally surprised by the agency’s actions, most FDA investigators follow a predictable script. Knowing this, you can be prepared for the inspection. Your next FDA inspection will be more successful when you are prepared.

Of course, we recommend that you periodically conduct an internal compliance review (mock audit). We can send you a free mock audit checklist that your compliance personnel can use to score your company’s compliance.

Free FDA Support Documents for GAWDA Members

Mock Audit Protocol contains over 140 questions to help you score your own compliance with FDA’s regulations.

GAWDA Training Record is a form to record your FDA, OSHA and DOT training.

Annual Records Review is a quick, one-page checklist to record your compliance with 21 CFR 211.180(e).

Sample Facility Cleaning and Inspection Record is a checklist that can be easily customized for your operations.

Food Gas Registration Worksheet is a step-by-step form to guide you through the food gas registration process.

Additional free resources for GAWDA Members include GAWDA University, the GAWDA Food Gas Roundtable, which is a monthly teleconference re the latest in food gas compliance, and CGA Publications available to GAWDA members who participate in the safety program.

If a formal mock audit is not practical for your business right now, here are eight simple and quick things to do to help prepare for a successful FDA investigation:

  1. CGMP Training – Be sure your personnel involved in filling medical gases have received Current Good Manufacturing Practices training within the past 12 months. If you cannot quickly find the training records, consider using GAWDA University as a training resource. GAWDA Medical Gas SOP Program Members receive CGMP training each month and through their Dropbox.
  2. Function Specific Training – Be sure you have records that you have trained your personnel within the past three years about how to fill the medical gas cylinders/containers.
  3. Annual Records Review – This process is quick and simple. You review a sample of the fill records, any complaints, etc. to see if your procedures need to be revised.
  4. Cleaning and Inspection – Be sure you have records that your facility has been cleaned and inspected on a periodic (e.g. monthly) basis. Look for evidence of rodent or insect activity.
  5. Calibration Records – Be sure you have calibration records for gauges, thermometers, scales, etc. Be sure all items are within their calibration interval.
  6. Food Gas Registration – Be sure your production AND warehousing locations that handle food gases (beverage carbon dioxide, etc.) are registered with the FDA. This is an easy process and is due between 10/1 and 12/31 of even numbered years.
  7. Food Gas Bulk Qualification – Be sure you have a certificate of conformance or certificate of guaranty from your bulk supplier that they supply food grade products to you. This should be repeated annually.
  8. Affidavits – Be sure your personnel understand that your attorney should review affidavits from an FDA investigator before they are signed, if at all.

In the event that you cannot complete a full mock audit, these eight items and the support documents listed in the Sidebar can help you prepare for your next FDA inspection. Contact me for these free documents.

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 Blackstone, Massachusetts. Members can reach him at 508-883-0927 and at tom@asteriskllc.com.