If any inspection results in a compliance action from the FDA, or requires corrective action, our experience in compliance remediation can help you get a quick resolution to your deficiencies and back in a positive position with the FDA. We understand the FDA’s expectations, what is required under the regulations and how to successfully manage different remediation activities. Our remediation services have consistently resulted in success for our customers.
483/Warning Letter Response
Our typical approach is to review FDA documentation with your team and come up with a plan and respond within five days. We will work to help you develop realistic timelines and corrective actions to ensure that each item is resolved as soon as it is feasible, meanwhile providing the FDA with your assurance that you do take this matter seriously and are intent on compliance.
If any of these items require additional resources beyond your capability, we can either provide resources from our company or other specialists who will ensure your deadlines are met and that systems are in place to ensure future success. We can also participate in meetings with the FDA or internal meetings to support compliance efforts.
Consent Decree
Consent Decrees are legal agreements between the FDA and a company that has either continually received violations or has significant violations that pose a serious risk to the public. These documents come in the form of plaintiff vs. defendant and typically result in having to cease manufacturing and distribution of affected products until proof can be demonstrated to the FDA that appropriate actions have been taken to comply with applicable regulations. Failure to resolve a Consent Decree is costly in terms of financial impact, lost revenue and public opinion of your business. Many companies cannot recover from this type of action, however, with proper assistance, such actions are completely avoidable.
Reglera has been through the process of clearing a Consent Decree and understands what it takes to be successful. If you find yourself in this unfortunate situation, we have the understanding of requirements and the experienced team to ensure your success.
Remediation Activities
No matter what your remediation needs are, we have the staff to manage the process and to complete the required activities keeping you in compliance with applicable regulations. We have assisted numerous companies, both large and small, with their FDA commitments. Reglera allows you to acquire regulatory expertise efficiently without bringing on additional full-time staff.