Regulatory Remediations
Although Robert has not participated in remediating a consent decree as a consultant, he has shown on multiple occasions, while working at FDA, that he possesses the necessary regulatory experience needed to identify, document, and collect supporting evidence required to obtain this significant regulatory action on two occasions. Other regulatory accomplishments include Warning Letters, Product Seizures/Recalls and Import Alerts.
The following contains some of Robert’s regulatory/legal actions, where Robert has drawn upon his Agency experience to assist clients in remediating regulatory issues and identify significant GAPs in production and quality procedures.
APPLICATION INTEGRITY PLAN (AIP)
On one of the two consent decrees Robert worked on while at FDA, he participated in industry meetings with the companies and was then assigned the responsibility of reviewing an application integrity plan (AIP) and served as the lead compliance officer who directly dealt with the firm’s management to bring about corrections to where CDER accepted the firms AIP remediation plan. Robert was also one of the individuals assigned to review completed batch records prior to the firm being able to commercially distribute their products.
Robert also assisted Los Angeles District on a comprehensive inspection of a large sterile facility in Phoenix, AZ where significant cGMP deviations were observed. The main issue was that the firm was marketing non-validated sterile suspension and emulsion products. Once appropriate documentation was collected, the firm ceased production of the non-validated products and recalled all products within expiry date. The firm entered a consent decree of permanent injunction, but rather than initiate a proposed corrective action plan, they decided to go out of business.
Data Integrity
As a consultant, Robert has conduct audits at multiple sites where data integrity issues had been cited by FDA. In 2004 after Robert’s CV was first accepted by CDER, he conducted an audit to verify corrective actions initiated at a foreign API facility and to assess their effectiveness in preventing subsequent data integrity issues from reoccurring. CDER accepted Robert’s recommendations and a subsequent FDA inspection only found minor GMP deviations with no data integrity concerns and the Import Alert was lifted.
In 2008, a finished dosage pharmaceutical manufacturer, located in NJ was cited for GMP and laboratory data integrity issues. Robert suggested a remediation plan to institute an improved internal quality oversight of laboratory operations to assure that analysts have controlled access to the data archive system. The company’s remediation approach was presented and accepted by the FDA district office. The laboratory also instituted a procedure whereby all analysts must first demonstrate proficiency in using any new analytical instruments prior to using the lab equipment for sample analysis. The subsequent FDA inspection found only minor GMP deviations with no additional data integrity concerns.
Robert has used his Agency acquired knowledge of Consent Decrees and Warning Letters to help prospective clients institute the necessary system controls to help avoid these significant and costly regulatory pitfalls.