"Helping People Learn Compliance and Science" ^SM

REGULATORY ACTION PREVENTION PROGRAM

SERVICE DESCRIPTION

FDA has several layers of action which they can take against a CGMP facility if they find that the facility is not in a state of compliance with 21 CFR 210 and 211. These actions include (1) Issuance of a deficiency observation during on-site inspections. These are commonly referred to as 483’s in reference to the government form number on which the observations are documented. (2) Issuing warning letters which document substantial deficiencies with respect to all aspects of the CGMPs found by FDA through inspections for other means. And (3) Entering into Consent Decree, which are formal legal agreements between the company and the FDA which commits the company to an extensive review of their quality systems and subsequent corrective actions. Consent decrees are voluntary but represent the final step after repeated violations or first time significant findings of lack of compliance by FDA. Consent decrees are completely avoidable and should be avoided at all cost- because they cost a tremendous amount to correct. Companies under consent decree may fail to recover from the financial impact of the action. No company who has ever received a consent decree has been released from it.

Delphi Analytical Services has actively involved in acting as the court required “3rd Party Expert Consultant” contingent with companies under Consent Decree. From these experiences we have learned how and why companies get into trouble, but more importantly, how to prevent from getting in trouble in the first place. Our experience can minimize the likelihood of receiving 483’s, substantially reduce the likelihood of getting a warning letter, and all but eliminate the chances of every coming under consent decree.

WHO WILL VALUE FROM THE SERVICE

The following organizations will benefit from these services:

     • Any company operating under CGMPs should be aware of the impact of

        lack of compliance and would benefit from DAS’s experience in this area.

ADMINISTRATION

All consulting service contracts are individually negotiated. Please contact us directly for more details or to request a proposal or site visit.
 

               Request for Consulting Services

· Home · Corporate Overview  ·  Product Description  ·Product Price List  · Services Description

·  Product Purchase  · Press Releases  · Resources   · Privacy Policy  · Customer Service  · Contact Us 

Copyright © 1999-2008 Delphi Analytical Services, Inc.