FDA Audit Remediation

Transform Your Quality Compliance with Synergy Bioscience

In the highly regulated world of medical devices, a single FDA audit revealing noncompliance can have catastrophic consequences. One large medical devices company learned this the hard way. After receiving a Form 483 for significant noncompliance issues, they failed to take decisive action due to inadequate resources or a lack of commitment to quality. The following year, the FDA escalated the situation with a warning letter. Still, the company did not address its quality system issues seriously. By the third year, the FDA imposed a consent decree, effectively putting the company out of business overnight.

Faced with the daunting task of remediation, the company spent 11 months and half a billion dollars with no significant results. It was only when they turned to Synergy Bioscience that their fortunes changed. Synergy brought the company back into compliance in just 7 months, at a fraction of the initial cost.

Why Choose Synergy Bioscience?

Synergy Bioscience is not just another quality system consulting service. We offer real, practical solutions tailored to your specific compliance challenges. Our expertise is not in providing temporary fixes but in ensuring long-lasting compliance that safeguards your business and your customers.

Under 21 CFR regulations, your quality system is your shield. It must be robust and compliant to protect your business from FDA actions, such as warning letters or consent decrees. Unfortunately, many companies turn to staffing augmentation firms that supply temporary contractors without ensuring their effectiveness. These firms profit from your continued noncompliance, providing replacements to keep you paying without resolving the underlying issues.

Synergy Bioscience is different. We are committed to solving your noncompliance issues for good. Our focus is on supporting your business’s most crucial goals: revenue generation and profitability. With Synergy, you can trust that your quality system is in expert hands, allowing you to concentrate on growing your business.

Take Action Today

Don’t let non-compliance disrupt your business. Choose Synergy Bioscience as your partner in achieving sustainable compliance. Contact us today to discuss how we can support your quality system and ensure the safety and success of your organization.