If you received a letter from the FDA, and it said the following, would you know what it meant?

“Written procedures are not established for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.”

No? Don’t worry, let me translate. This excerpt is from an actual 483 letter (a list of observations that should be corrected after an FDA inspection), and is highlighting a FDA requirement that might be due for your firm this time of year: An Annual Records Review.

The US FDA has jurisdiction over any oxygen transfiller, and considers them a drug manufacturer.

Let’s unpack that: What’s a transfiller? Anyone who transfers oxygen from one container to another. Why does the FDA consider that manufacturing? Because that movement from one container to another could affect the purity of the oxygen.

In our industry, that means that anyone who performs gas to gas filling, liquid to gas filling, or liquid to liquid filling is considered by the FDA to be a transfiller—and thus a drug manufacturer.

So, if the FDA considers you a drug manufacturer, what does that mean? It simply means that you’ll have to do a few things to ensure your patients are getting the correct purity oxygen, and the FDA will check that you do those things. One of those things is the annual records review.

Annually, quality control personnel should review the batch production records and the complaint files to see if there is any need to improve the current manufacturing process.

For this annual review, you should:

1. Make sure the records you are reviewing are easily accessible in the event you have an FDA Inspection.
2. Review and document the batch production records and other filling logs.
3. Review and document the complaint files and procedures.
4. Assess, document and implement any changes that need to be made. If no changes need to be made, indicate that there are no changes.
5. Document who and when the records were reviewed.

Got any other regulatory questions? Contact Victoria at vmarquard@applied-inc.com and your question could be featured in Home HealthCare TODAY!