Dealing with an FDA remediation issue can be a serious and intense process. At EKG Labs we provide FDA remediation services that help guide clients through what can be a stressful experience. Our Quality team has experience communicating with the FDA and we can leverage that experience to help you address your current situation.
FDA Form 483 Resolution
The last thing any pharmaceutical or medical device manufacturer wants on their record is a FDA form 483 or warning letter. Effectively responding to these regulatory deficiencies requires cohesive planning and thorough documentation. EKG Labs can help you assemble a complete FDA response package.
Typical service offerings include:
- Analyzing the results of the 483 or warning letter
- Gathering supporting documentation to file with the response
- Creating a timeline that meets agency expectations
- Answering any of your questions or questions from the FDA
- Assisting in the creation of effectiveness checks
- Developing a remediation plan to correct and further prevent the deficiencies noted in the 483 or warning letter.
Consent Decree Resolution
It is important for a manufacturer to understand the FDA’s concerns in terms of the applicable regulations and potential systemic failure. A successful resolution of a consent decree requires patience, focus and commitment. Experienced professionals at EKG Labs will partner with you to help revamp and resolve deficiencies in your Quality System.