Indian Rocks Beach, FL 33785
(727) 642-0182
(813) 774-8657
(727) 593-3595 FAX
"Helping People Learn Compliance and Science" SM
CONSENT DECREE CORRECTIVE ACTION PROGRAMS
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 Decrees, 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.
Delphi Analytical Services has been extensively 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, and how to get companies out of trouble once they come under consent decree. Our experience has taught us how to (1) Systematically and effectively perform audits (2) Document the findings (3) Design corrective actions (4) Develop and implement corrective action plans (5) Mentor company personnel during corrective plan implementation and (6) Verify if the actions have been properly completed. We can also assist in implementing a monitoring and feedback plan to insure companies do not become recidivistic.
WHO WILL VALUE FROM THE SERVICE
The following organizations will benefit from these services:
• Any company who is about to or is operating under a consent decree wouldbenefit 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.
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