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 us translate. This excerpt is from an actual 483 letter (a list of observations that should be corrected after an FDA inspection) and highlights an FDA requirement that might be due for your firm this time of year: An Annual Records Review.

The U.S. FDA has jurisdiction over any oxygen transfiller and considers them drug manufacturers.

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, 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 therefore a drug manufacturer. 

So, if the FDA considers you a drug manufacturer, what does that mean? It means that you must take specific steps to ensure your patients receive the accurate purity of oxygen, and the FDA will verify your compliance with these procedures. One of those things is the annual records review. 

Quality control personnel should review the batch production records and the complaint files every year 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 if 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 when the records were reviewed. 

Have another regulatory question? Contact us at registration@applied-inc.com!