Failing to investigate an out-of-specification result adequately can easily earn you a warning letter.
A case study on Investigation of OOS Case Study on Microbial Test | FDA Warning Letter.
Today, I’m going to talk about an FDA warning letter sent to XYZ Biotech.
A Biotech company situated in the USA and specializes in ear care products.
They have received the unpleasant notice because they have failed to investigate an OOS properly where they had identified during a microbial test.
Additionally, the sample turned out to be positive for gram-negative rods.
It is a critical issue because microbiological contamination of these products can pose a severe hazard to patients.
What would you have done in such a case if you were a QC or QA manager?
I hope that your answer was not instructing the lab to throw away the results and repeating the test with a new sample.
Because that what the company did!
The re-test was a pass, and the company used it to approve the release of the batch.
The company didn’t perform any investigation to determine the cause for microbial contamination and conclude whether other lots could have had the same problem.
But this was not the only case where the company failed to investigate an OOS thoroughly.
On a different occasion, the lab has found that three batches of ear-drops failed the APC test.
This time, they have performed an investigation and determined that most likely, there was an issue with the water.
Eventually, they have rejected the lots.
Another Point Is! However, the company didn’t get to the root cause of the problem, and they didn’t figure out why the water got contaminated.
Additionally, it conducted no research, whether other batches could have been affected by the bad water.
So, what mistakes has the company made that lead to the warning letter?
First of all, the company should have conducted an extensive root cause analysis to understand the contamination source.
The microbes must have come from somewhere, right?
Was part of the batch contaminated, or did the operator contaminate the sample during the sampling procedure?
Either way, the company should have gotten to the bottom of the events and created adequate CAPAs to ensure such events wouldn’t happen again.
Otherwise, their process will stay broken or the personnel untrained.
Additionally, they should have reviewed whether the failure could have affected other batches or products.
What if they used the same contaminated medium for different batches, but they didn’t sample the contaminated parts?
You always have to think broadly and not take such deviations lightly.
But, let’s assume the company has investigated the OOS but couldn’t find the root cause.
Would it be ok to release the batch then?
In this case, I would strongly suggest against doing that without conducting a risk analysis, demonstrating that releasing the product wouldn’t have any adverse effects on the consumers.
Correct deviation and issue management are vital for compliance.
On this note, I wish XYZ Biotech on Investigation of OOS Case Study on Microbial Test | FDA Warning Letter.
The best of luck in eliminating their regulatory problems quickly and efficiently.
I hope you enjoyed the investigation of the OOS Case Study on Microbial Test | FDA Warning Letter article and found it informative.
Stay compliant, and see you in the next one!