6 Reasons to Get Expert Help When Handling Warning Letters & FDA 483

FDA Warning Letters and Form 483 Inspectional Observations, while not final determinations, are extremely important for companies to fully evaluate and resolve. What may seem like simple deficiencies in your quality system can be just the tip of a huge compliance iceberg floating just beneath the surface.

All too often these issues become low priorities for those responsible for quality assurance and regulatory compliance, opening the door to costly enforcement actions down the road when seemingly small issues develop into much more serious problems.

Free White Paper: The Emergency Guide to FDA Warning Letters & FDA 483

Situations like this can easily be avoided altogether by leveraging the knowledge, experience, and expertise of a skilled life science resourcing firm who can pair your company with experts — some of whom may even be former FDA —t o the specific areas requiring evaluation and correction.

To help you take the best path toward recovery, we’ve put together a list of the six biggest ways an experienced compliance and remediation consulting firm can help those recovering from a Warning Letter or FDA 483.

1. Objective, un-biased perspectives 

Many companies have internal auditors on-staff to regularly assess quality systems throughout the organization. While these teams are extremely valuable for maintaining compliance, it can be difficult to gain a truly objective perspective on problems when they arise.

By bringing in a third party expert, you gain the advantage of casting a fresh set of eyes on problems and root causes that may not be apparent to those on staff. This new point of view, when combined with experience and expertise in a particular area of focus, not only allows you to better evaluate problems, but also clues your staff into different ways of approaching quality standards and remediation in the future.

2. A comprehensive understanding of CAPA

Related to the previous point, the objectivity of an outside expert also allows you to take a new look at the CAPA Plan you’ve put in place or are planning to execute for the first time. 

Read Also: 5 Tips for Writing an Effective FDA 483 Response

Unlike tasking someone on staff with the job of improving or building a CAPA Plan, consultants have likely spent years helping companies in your position. They know what to look for and how to write documentation and records to satisfy the expectations of regulators.

3. An eye for spotting compliance gaps you may otherwise miss

Experienced consultants spend years evaluating and auditing records, systems and other areas of quality. As such, they develop an extremely sharp eye for spotting gaps that may otherwise be missed by your staff. 

[Read Also:] A 5-Step Guide to FDA Warning Letter Recovery

While resolving the particular problems cited in Warning Letters and FDA 483 is certainly the first priority, it’s often the case that the same or similar issues may exist in other systems or records. A skilled expert can easily spot these when conducting a thorough investigation.

4. Knowledge of an ever-changing regulatory environment 

When compliance issues arise, attempting to handle the problem internally usually forces staff out of their day-to-day routine to focus on something different than what they’re used to doing day in and day out.

This can be problematic, especially when bringing an antiquated mindset to an area with a whole new set of expectations. 

For consultants, this is their day-to-day routine. They keep up with the latest developments in FDA guidances and know exactly how to evaluate and correct issues to satisfy current expectations for quality and compliance.

5. Strong relationships with FDA

Experience, knowledge and expertise in a particular field aren’t the only things consultants bring to the table when helping a company recover from compliance troubles. They’ve also likely developed a strong relationship with those inside FDA who will be dealing directly with your situation. 

This can be an invaluable advantage when communicating directly with regulators to decide with approach to recovery is the best one to take.

6. Access to former FDA staff

Even more valuable than a strong relationship with FDA is having personal experience within the agency itself. While not every firm can offer such an intimate level of assistance, those that do provide definitive answers to the most difficult questions while offering an unparalleled level of expertise and knowledge into what needs to be done to resolve compliance issues quickly and comprehensively.

Here at The FDA Group, we offer a large staff of over 340 consultants (55 of whom are former FDA Investigators) capable of tackling virtually any compliance issue you may be experiencing. 

Want to learn more about Warning Letter or FDA 483 recovery? Grab our free whitepaper, The Emergency Guide to FDA Warning Letters & FDA 483 for a step-by-step guide. Need expert assistance immediately? Contact us today to get started on your next project.

Topics: FDA Warning Letters, FDA Form 483, FDA Auditing, Compliance Consulting