FDA Warning Letters, 483s, and Funnel Clouds: What do tornadoes have in common with FDA inspections?
Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions
What do inclement weather and FDA inspection results have in common? Whether you want to believe it or not, they can both escalate from serious to disastrous fairly quickly. For anyone who’s spent significant time in the Midwest or tornado alley, it’s common knowledge that a tornado warning is more serious than a tornado watch. The truth is, the tornado alert system has quite a bit in common with FDA inspections, FDA Warning letters, and FDA form 483s. Let’s take a closer look.
Watch out! You’ve received an FDA Form 483.
When dangerous conditions exist, the National Oceanic and Atmospheric Administration (NOAA) issues a tornado watch. While it may not signify immediate danger or severe weather, it’s a sign that atmospheric conditions are raising the risk. This is similar to an FDA Form 483: the conditions exist for risk of noncompliance with regulations affecting public health and safety.
Tornado: narrow, violently rotating column of air that extends from the base of a thunderstorm to the ground.
What is an FDA Form 483?
For Life Sciences organizations that must meet FDA regulatory requirements, a Form 483 is a written notification listing observations found during an inspection. Typically these are violations of the Food, Drug and Cosmetic (FD&C) Act, and they are presented at the end of the inspection. It’s also referred to as a Notice of Inspectional Observations.
After a Form 483
Once your firm’s management has received an FDA Form 483, the observations are discussed with the inspector. As a follow-up, the firm should send a written communication detailing the corrective and preventive action (CAPA) plans for the objectionable conditions cited in the 483.
Act now! You’ve received an FDA warning letter.
Once a tornado has been sighted or touched ground, a local office of the National Weather Service (NWS) issues a tornado warning, a more imminent danger than a tornado watch. Typically, newscasters and radio jockeys will announce the areas in its immediate path and advise everyone to take cover. A destructive force of nature, a tornado has the ability to cause countless amounts of damage to property, and unfortunately to people. As many who have encountered tornadoes year after year know, being in its path does not necessarily lead to damage; there is still an opportunity to remain unharmed.
Similarly, once your organization has received a warning letter, you have the opportunity to correct conditions cited in the observations and implement changes to help keep your reputation unsullied. You will need to make it clear how you are correcting the issues to prevent recurrence. You will want to ensure your quality system is in full compliance with the regulations.
What are FDA warning letters?
“The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform FDA of its plans for correction. FDA then checks to ensure that the company’s corrections are adequate.”
Why did you receive one?
But wait, why did you receive the FDA warning letter in the first place? After an inspection, the FDA Form 483 and its corresponding Establishment Inspection Report—along with any collected evidence from inspection and responses from the company (remember those CAPA plans?)—are considered with regard to public health and safety. Based on all available information, the FDA will determine whether any FDA warning letters are needed to escalate the regulatory violations.
The Aftermath: Emergency Relief
Once you’ve received a Warning Letter, you may find your organization unable to clean up the damage from the storm alone. You may be unsure how to adequately correct the violation cited in the letter, or how to implement the right CAPA or the most effective CAPA within an acceptable time frame from the FDA. Just as relief organizations often provide assistance after a tornado hits, outside consultants can serve as your emergency relief team. The last thing you want is for the FDA to shut down your facilities.
An outside consulting firm can help you prepare your response, suggest an appropriate timeline to satisfy the FDA, and ensure your quality system can meet the respective regulations for your business. With or without relying on outside help, your firm’s main goal should be to correct the observations and ensure your quality system is in compliance. Once the conditions escalate past a warning letter, they can lead to a consent decree—a legal injunction which can mean the inability to release your manufactured products to market or the shutdown of your facilities—or to field actions and recalls.
Avoiding FDA Form 483s and FDA Warning Letters
No one wants to be in the path of a tornado (especially if it means having a house dropped on you and losing your ruby red shoes!), just as no one wants to receive a Form 483 or FDA Warning Letters. For medical device manufacturers, pharmaceutical companies, and those in vaccines and blood and tissue, the best way to avoid the path of the storm is to have a rock-solid quality system.
Year after year the number one reason for FDA Form 483s is an inadequate CAPA process. To prepare your organization, ensure your quality system includes a consistent and controlled CAPA process.
Likewise, you will want to always remain prepared for inspection. When the FDA knocks on your door, you should be prepared to showcase your quality system. A well-defined internal audit process can help your team identify weaknesses in your quality system, and allow for correction, to help you continually improve your quality management process and boost product quality.
Pilgrim’s SmartSolve® quality management software can help you remain in control and in compliance. SmartSolve is a highly configurable platform for achieving compliance with industry regulations across global operations. Based on ISO standards for quality management systems, SmartSolve delivers electronic signatures, validation packs, and electronic reporting to meet a wide array of quality management process needs.
And, SmartSolve delivers real-time audit support from the Pilgrim team. When you are actively involved in an FDA or regulatory audit, your SmartSolve requests are immediately escalated so you’ll have our help accessing the critical data and reports you need to be prepared.
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