FDA Inspection and Remediation

Preparation and Accompain­ment during FDA Inspections

Has the FDA announced its arrival? We will ensure your inspection's success.

1. We start with a GAP analysis of your docu­ments and give you concrete sugges­tions to eliminate non-conformities.
2. We check implementation and compliance in an internal audit.
3. We train you in the correct behavior during inspections and ensure learning success during a mock inspection.
4. We accompany you during your FDA inspection and coordinate your war room on request.
5. We help you with follow-ups and responses to the authorities or take over these tasks.  

Remediation

Has the FDA already identified deviations? Then, we can eliminate them.

1. We help you understand the deviations and formulate objections and responses to the authority.
2. We create a remediation roadmap for you and coordinate it with the FDA.
3. On request, we implement the measures (with you) and improve the documentation, for example.
4. We check the effectiveness of the measures and prepare you for a possible FDA inspection.
5. We communicate the implementation with the FDA and ensure that the authority closes the case in your favor.  

And if the matter has already escalated, we will put together an “emergency team” that will clean everything up in the shortest possible time.