Be prepared for 483s
Whether you have a medtech startup or a well-established medical device business, the inevitable is bound to happen—483s and warning letters. It isn’t a matter of if you can expect these letters, it’s a matter of when. When you receive a 483, though, don’t panic. QuickConsult can help you the entire way, from response to action. You aren’t alone when it comes to matters of compliance and potential issues, especially with the quick and reliable help of QuickConsult.
What counts as a compliance, regulatory or quality warning?
You may receive a 483 at some point after being inspected by an FDA investigator. Don’t lose sleep over it—thousands of others will receive 483s from the FDA in the average year, too. Whether you’re wondering how to navigate a common 483 to a less common consent decree, QuickConsult experts have been there and done that. They know how to promptly and adequately respond to any sort of compliance or quality warning you might receive.
What is FDA Form 483?
What is this ominous 483, anyways? Once an FDA investigator has completed an inspection, you might receive a 483 if, per the investigator’s judgment, a condition or practice was observed that could render your drug or device harmful or not up to quality standards. A slump in standards could be observed anywhere from preparation to packaging, but you won’t be left to guesswork as each observation should be highly detailed and specific.
There are three types of FDA inspections: Pre-approval Inspections (PAIs), Routine GMP inspections and “For-cause” inspections. PAIs will happen to “verify existence of raw data included in the submission” as well as to ensure your facility can manufacture your device to meet specific standards. Routine GMP inspections will take place every 2–3 years for manufacturers and “for-cause” inspections are triggered by a recall, a cluster of adverse events or another “event” where the FDA deems necessary to focus an inspection.
After an inspection has taken place, the investigator should discuss their observations with you so you fully comprehend them and the implications they carry. Note, an investigator will only tell you what they saw and the responsibility still lies with you and your company to address any non-cited conditions that might still exist. It’s also important to remember that receiving a 483 isn’t the be-all, end-all. Different FDA groups will review a 483 given by an investigator and will determine what action and remedy, if any, is required of you.
What is a Warning Letter from the FDA?
A Warning Letter from the FDA differs from a 483 in that it directly addresses identified issues, provides directions for correction and gives a company a time frame in which to provide the FDA with a plan for how those corrections will be completed and when. A Warning Letter will identify your specific violation and tell you what has to be done in order to correct that violation. These violations can range from manufacturing problems, product claims or incorrect use directions.
There are several differences between a Warning Letter and a Form 483 despite both providing information about what corrections need to be made. A 483 provides you with a list of observations made during an inspection; these observations might not need to be acted on until higher FDA officials deem it necessary. After higher FDA officials have reviewed a Form 483 and they decide noted issues need to be addressed or corrected, they will then issue a Warning Letter for a serious violation. Warning Letters require action while 483s suggest actions to be taken.
What is a Consent Decree?
Consent Decrees aren’t very common, but they are a very serious matter. Once a med tech company has been found in fault of violating requirements, the FDA issues a Consent Decree to force the company to make required changes. This is a legal agreement that is enforced by federal courts and usually includes fines, reimbursement to the government for inspection costs, and penalties for noncompliance. Like a Warning Letter, a Consent Decree will include specific dates by which specific actions have to be completed. Consent Decrees can be overwhelming and especially costly when handled incorrectly. Don’t get caught with an overwhelming Consent Decree—instead get the help you need quickly from QuickConsult.
Why you need QuickConsult for you FDA remediation
QuickConsult has the experienced resources you need now. When you’re faced with a 483, a Warning Letter or even a Consent Decree, simply log on, choose your expert and get started immediately. Your experience is up to you: Either choose an expert for a single question or use your expert for prolonged consulting. It’s like having an on-demand supplemental employee who has the know-how and experience you need now. Our experts can assist you with:
- FDA Form 483
- Warning Letter Guidance and Review
- Consent Decrees
- Design History File (DHF) Remediation
- Risk Management File Remediation
- Test Method Validation Remediation
- Process Validation Remediation
Save yourself time, money and resources by getting everything you need in one spot. Our pool of experts range from ex-FDA to VPs of Fortune 500 companies. They’ve lived and breathed med tech, so they can help you—guaranteed. Once you enter the issue or question you’re facing, you’ll quickly be met with viable experts who can help you solve your problems. Review each expert, their bios and credentials, then pick the one right for you. You aren’t faced with inexperienced people or robots pretending to be people. These are real experts with real experience who are all waiting to help you today with your FDA remediation needs. So, let’s get started!
QuickConsult FDA Remediation Experts
QuickConsult experts have experience across numerous product and therapeutic areas, including but not limited to cardiac rhythm, cardiovascular, diabetes, ear, nose & throat, gastroenterological, general surgery, medical supplies, neurological, orthopedic, patient monitoring and recovery, reconstructive/plastic surgery, spinal, surgical innovations, urological/urogynecological, vascular therapies and mobile apps. Their expertise spans management- to executive-level backgrounds in Fortune 500 organizations to startups.
“QuickConsult is like having a really good friend who’s a really good expert, in your back pocket, that you can … ask a tough question! [QuickConsult] provides that network in a way that is easy access, vetted people in an environment that you can trust and be protected. I think that’s invaluable.”
– Susan Alpert, MD, PhD, former FDA Director
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