Medical Device Compliance: Recovering from FDA Warning Letters

You have received one of the dreaded FDA Warning Letters. The last thing you want is to delay the launch of your company’s latest innovation. However, you cannot risk shutdown for non-compliance and the possibility of never making it to market with your latest brainchild.

In a perfect world, you want to prevent the need for ever having to receive an FDA Warning Letter. But now that you have one in hand, how do you respond and subsequently remediate your production and management operations within the constraints of your business needs?

You will need to ensure that you are operating in full compliance while still meeting your go-to-market goals and instituting best practices throughout your procedures, thus remaining compliant with the predicate rules and 21 CFR Part 11.

Evaluating the Letter and the Impact

When receiving an FDA Warning Letter, your timely response of 15 days is required. Submitting a CAPA plan is a mandatory part of your response to each of the issues flagged.

The comprehensive action plan you outline must address a prompt correction of each observation called out in the letter. Note that these items are tied to observations made during the FDA inspection of your facility or may be related to an advanced warning you received in the form of a 483.

Each of the FDA inspector’s observations made during the inspection period must be addressed such that short-term, mid-term, and long-term activities are defined together for a period during which your corrective and (more importantly) the preventive actions are planned and executed.

If a device warning letter includes cGMP violations, the FDA also adds: “Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.”

Taking Preventative Measures for Future Compliance

You want to prevent the recurrence of Form 483 and FDA Warning Letters. While no action plan is foolproof, compliance can be addressed most effectively by instituting robust quality systems management plans.

You want to set high goals for maintaining your already stringent policies, ensuring efficient and consistent operational standards. Performing a walk-through for each segment of your operating procedures, measuring the accuracy, recording any variations and deviations, and noting what falls close to the non-compliance line in each sequence is a successful strategy to employ.

Consider multiple paths toward more effective compliance throughout your entire operation. Best practices might also include reviewing the most current medical device regulations and applying those requirements to your quality management systems standards by including the use of:

FDA medical device regulations regarding cybersecurity
FDA software validation principles
Self-audits to improve your supplier quality and performance
Deviation management used in conjunction with CAPA remediation

Obtaining Expert Help

You have several corrective modalities available to you for aligning and remediating your operations after receiving an FDA Warning Letter. You might need to combine strategies or rethink your quality management approaches. If you are responding to your first warning, the entire process can be a challenge.

No matter how you proceed with your preparation and response, understand that every company gets thrown a curveball now and again, and sometimes all you need is a little coaching to get your team winning. That is where GxP-CC can help. They’re well-versed in the FDA Warning Letter response and have notable training and expertise in understanding regulatory requirements for data integrity into life sciences.

This can be especially valuable when evaluating your quality management systems. Contact the consultants at GxP-CC today and see how they can help support your efforts.

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