FDA Gets Aggressive With Inspections

6 need-to-know compliance issues for food gases and medical gases.

We are seeing some unusually aggressive FDA inspections at GAWDA members who are committed to full compliance. This new enforcement seems to be happening more along the northern half of the US…for now. The best way to be ready for a difficult inspection is to be sure you are in compliance right now. Consider your compliance on the following items:

Affidavits
We are seeing more requests for GAWDA members to sign affidavits about their inspection. Instruct your employees to NEVER sign an affidavit without consulting your company counsel. Many companies simply have a policy against signing affidavits. The inspector may pressure you to sign—call your attorney first!

Expiration Dates
If you are still using expiration dates on your medical gases, you are at great likelihood of receiving a Form 483. The actual violation will be for the absence of a “stability study” to justify expiration dates. Consider discontinuing expiration dates immediately for your medical gases.

You may have some customers who are likely to object to the discontinuation of expiration dates. In these situations, clear communication is key. (For a sample customer expiration date notification letter, contact juliet@asteriskllc.com.)

Cleaning and Maintenance Records
This applies to both drug and food inspections. It is not enough that you have a clean and orderly fill plant, you need to have cleaning/inspection procedures AND a record that you have complete the work. (You can get a sample inspection form by contacting Juliet at the above address.) Cleaning and maintenance need not take a lot of time…just be sure it is documented.

Oxygen Manifold Cleaning
Be sure that the leak check solution you use on the cylinders does not leave a residue on the manifold. Your leak checking solution is likely safe for oxygen service and represents no purity issues. However, it’s not worth an argument with the FDA over this issue. Simply have your manifold cleaned of external residue periodically.

CGMP Training
Be sure all your Quality Control Unit and operations personnel all have up-to-date Current Good Manufacturing Practice training…and that you have the records to prove it. You can get free/low cost training from GAWDA University or your FDA technical support consultant.

Fill Logs
We are seeing inspectors go through a thousand fill logs in several locations. Be sure every log is completely correct and released by your QCU. It’s arduous work and requires great attention to detail.

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 tom@asteriskllc.com