In this article, we will share about How to Avoid Such Unfortunate FDA Warning Letter | Case Study of Market Complaint
Failing to investigate complaints adequately can easily earn you a warning letter – a case study and how to avoid such unfortunate situations coming up!
In this type of article, we examine the regulatory mistakes made by companies worldwide.
Those errors cost them an FDA warning letter, and this is vital that we learn from them. Today I’m sharing a warning letter received by Xyz Corporation, a company located in the USA.
The one product they sell, which falls in the USA under the drug entity category is called After Bite, and its purpose is to reduce itching after getting bit by a bug.
After using this product, some children developed blisters, rashes, and pain.
As a result, their parents, I would presume, filed complaints with the company.
The company does have procedures in place to handle such complaints.
That includes thorough analysis, investigation, and implementation of CAPAs to address and respond to complaints. On paper, everything seems OK.
However, the FDA found out that the company closed multiple complaints investigations without determining a root cause or implementing effective CAPAs.
For example, the company closed one of the complaints based on the assertion that the complaint profile was low and batch testing met specifications.
Thus, the company has concluded that the product was safe and effective.
HOW TO AVOID/ HANDLE
- First of all, concluding that an event has a low impact on the consumer’s health is not an excuse to close complaints or deviations.
- The company should have investigated what caused the consumer to experience unpleasant side effects.
- If it was indeed their product, they must have conducted an extensive root cause analysis to understand what has happened.
- After finding out the cause, they should have investigated whether other batches were affected by the failure.
- In the end, they should have created effective CAPAs to make sure the situation wouldn’t repeat itself.
- The process of issue investigation throughout the product life-cycle is a vital part of the quality management system.
- Therefore, Mishandling deviations can quickly get you in trouble with regulators.
Thanks for reading How to Avoid Such Unfortunate FDA Warning Letter | Case Study of Market Complaint