Ins and Outs of the FDA Warning Letter Process
07-24-2012
The number of warning letters issued by the U.S. Food and Drug Administration (FDA) jumped from 673 in 2010 to a staggering 1,720 letters in 2011.
With this upward trend in warning letter activity, companies should have a comprehensive understanding of the process. What triggers a warning letter to be sent? When do you need to respond? What will cause the media and the general public to pay attention?
I recently wrote an article for Pharmaceutical Processing, the first in a five part series on warning letters, answering such questions and providing an overview of the warning letter timeline.
FDA uses warning letters as a way to encourage businesses to voluntarily comply with industry standards and regulatory guidelines. This type of action usually follows a routine or complaint-triggered inspection and a Form FDA-483 document, which addresses any deficiencies found at a facility. The form is given to the firm at the completion of the inspection and can be addressed by company officials either through an exit discussion and/or a formal written response. Inspectors can also choose to draft an Establishment Inspection Report (EIR) that provides more detail on observations made during the audit.
A warning letter is sent only to a company when senior FDA officials deem the existing violations cited within the Form 483 and EIR to be significant in nature.
Once the letter is sent, firms have 15 days to respond with the corrective actions that will be taken to resolve the issues outlined in the warning letter. Otherwise, FDA may take further regulatory action in the form of seizures, injunctions and civil money penalties.
It is important to understand that the issuance of a warning letter is not necessarily a prerequisite to regulatory enforcement action. In fact, FDA can bypass the warning letter phase altogether and immediately take action if a company’s violation fits certain criteria.
My next article in the Pharmaceutical Processing series will take a look into what firms can expect from FDA inspections and how to best prepare for such occurrences. With this knowledge on-hand, businesses will be better able to anticipate what will happen during a FDA inspection and better assure regulatory compliance.
Do you feel that your firm is well-versed in FDA regulations and regulatory actions? Are you effectively prepared to take the proper steps to comply with FDA warning letters? Please share your thoughts below.
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