Avoid FDA Form 483: Use Your CAPA Program to Stay Ahead of Auditors

This year has seen a significant rise in Form 483s following FDA site visits. Plant management is getting caught off-guard when on-site auditors fixate on items that weren't in the scope of previous audits. If the FDA sees a product on hold for something out of range, they may ask if internal food safety investigations are in motion and if appropriate action is being taken. 

Auditors are more thorough in determining whether manufacturers have a robust Corrective and Preventative Action (CAPA) program. Manufacturers must demonstrate multi-faceted activity to determine if a hazard exists and assess the nature/extent of the issue. Avoiding a Form 483 is about giving the FDA confidence in your CAPA program and truly understanding what they’re looking for and why.

FDA Form 483

Although it may not feel like it at times, it’s helpful to consider the FDA as a valuable collaborator to food manufacturers. In helping to protect public health, the FDA is also safeguarding food manufacturers from what could be detrimental economic burdens and public backlash from recalls and lawsuits. That’s why it’s so important to understand what the FDA is looking for when investigators perform an audit.

The FDA Form 483 is issued when an investigator observes potential violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. This involves compromising the integrity of a product, or in the preparation, packaging, or storage of a product, in a way that could cause a potential food safety risk. 

When served with an FDA Form 483, the required response is to present the FDA with a corrective action plan. That being said, the best defense is a good offense. You can head off the likelihood of an FDA Form 483 by having a strong CAPA program in place before the auditor even shows up. The more confident the investigator is in your CAPA program, the more likely you’ll avoid the FDA Form 483 and resulting delays.

In our recent webinar, Shoring Up Your Prevention Actions to Avoid FDA Form 483, Lacey Keesee, Director of Food Safety at TAG, helps food manufacturers learn how to build a CAPA program to FDA standards.

It’s all in the details

Manufacturers must be able to tell the FDA a story that answers “are you able to maintain control of a robust food safety program?” Proper documentation, as in start-to-finish investigation details, will help instill confidence in your CAPA program.

CAPA programs serve two purposes: to have an established plan for “corrective actions” to fix problems as they occur, and a plan for “preventive actions” to avoid potential problems before they happen.

Even if your business already has CAPAs established, a less-than-optimal plan can contribute to an FDA Form 483. Your CAPA program should contain as much relevant detail as possible to prove you have a solid prevention action plan. 

Get to the root of the issue.

Many times, manufacturers will resolve an individual customer or consumer complaint without looking at the problem holistically to find the root cause. As a result, more customers may have the same issue. This is a good example of companies that have a corrective action plan in place, but where the preventive actions are falling short. 

 Repetitive customer complaints regarding the same issues are major red flags to auditors and can trigger an FDA Form 483.

To develop a good preventive action plan, companies must not only investigate what triggered the event but also whether similar problems could occur for other customers or products. It’s also a good idea to perform a risk analysis that determines the potential consequence of not thoroughly investigating and correcting known issues, so they don't turn into larger problems.

Integrate a Root Cause Analysis process.

Develop a Root Cause Analysis (RCA) process at the forefront of your plan. By systematically determining the underlying reason for how or why an event occurred, you can correct it, eliminate it, and prevent it from recurring. Each root cause must have its own CAPA.

It’s often difficult to determine the root cause, and many companies often incorrectly identify contributing factors as the root cause. As such, a root cause that goes uncorrected can escalate a one-off issue to a large-scale problem that affects multiple customers, consumers, or products.

However, how can you tell when a root cause has been identified? 

Proper CAPA management requires effort. Compiling CAPA-related information, keeping it organized, and documenting it properly can be challenging. Reports can go overlooked, leaving issues effectively resolved. Be sure to keep key stakeholders in the loop and have management sign off on steps to ensure you’ve thoroughly addressed the root cause and contributing factors of an issue.

Don’t drop the ball: follow up with your customers.

Make sure you follow up with customers to see if your corrective actions have been effective and make sure they haven’t been affected by new unforeseen issues. Any new problems should be solved as soon as possible, so they don’t turn into larger issues across many customers and products.

Document everything — securely.

Gone are the days when a file cabinet stuffed with paperwork would suffice. (And good riddance!) Modern manufacturers can’t stay organized or efficient with antiquated record keeping, as the FDA will ask for detailed historical records, not estimations. Companies must maintain organized, digital start-to-finish records of internal investigations when responding to customer complaints or outbreaks. 

The benefits of maintaining a detailed data history are threefold: 

1. Helps to create or improve an internal investigative response plan

2. Helps build FDA confidence in your ability to control your environment

3. Helps prevent further investigations or shutdowns by FDA

Resources like SafetyChain that can help with CAPA reporting and monitoring trends are a powerful tool to ward off the FDA Form 483.

Don’t wait for the auditor to show up.

Every single CAPA program is specific to the environment, facility, and customer needs. Manual record-keeping or one-size-fits-all point solutions will not enable your team to confidently prepare for and answer the FDA. Know your problems and strengths, and look for software that speaks to both.

The sooner you apply a solid foundation to your CAPA program, the more smoothly your audit will go — and the less likely you'll be faced with an FDA Form 483.

Want to learn more about building an FDA-proof CAPA program? Watch the webinar.