Warning Letter – Response Preparation – General

Service Description:

– Warning Letter – Response Preparation – General
– Warning Letter Review.
– Warning Letter Respond to include explanation steps to correct the violation(s) and prevent
future violation(s), Current contact information, List of adequate corrections to be
implemented to comply with all applicable laws and regulations.
– Service does not include FDA submission service(s).

Requirements:

– Submit your warning letter via email to services@consultareinc.com
– Submit your letter head via email to services@consultareinc.com
– Gap Analysis of your firm’s Quality System is not included in this service.
– Submission to FDA is not included in this service.
– Services are non-refundable.
– Google Meet – Screen Share for discussion. To be scheduled by our
Compliance Team, if applicable.
-Recommendation and guidance given or implied are based on best
practices and the adherence to a regulatory or certification body
requirements or a Quality System and may or may not conform to the requirements or the
intended use or application.

Deliverables:

– Warning Letter Response in word format.

Delivery Date:

– 1 to 3 Business Days upon receipt of completed information required for inputs.