Priyabrata Sahoo | MetricStream Inc.
Keep an eye for the warning signs in your internal procedures and processes to reduce the risk of being caught by the FDA.
Oops! I got the FDA warning letter. Now what should I do? How should I respond to prevent further enforcement actions by the Agency? And all the other barrage of questions scares you. Look at it differently. How do you foresee that a warning letter is coming? What are the signs that can help you anticipate a letter from the Agency? If you can do that, then hopefully, you can take steps to avoid one and resolve it before FDA knocks your door.
Warning Letter Trends
In the recent past the FDA has made an effort to speed up the warning letter program. This means that they will no longer build an airtight legal case before issuing the letter. Multiple warning letters are also no longer being issued. In some cases, the FDA has shown that it will not even issue a formal letter before shutting down a facility, recalling products or revoking licenses.