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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.
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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.
