Recent Examples:
Deficient Vendor Mgt Programs
Whether you are a sponsor or a third party, it is widely acknowledged that lack of communication is one of the most frequent issues in vendor management. Fortunately, it is also one of the easiest issues to address. The examples below demonstrate the importance of these interactions and how they can degrade operations to the point of clinical holds and shutting down operations.
Lack of Vendor Oversight
Bluebird Bio - December 2021
Cambridge, MA
Bluebird Bio faced regulatory scrutiny when the FDA placed a clinical hold back in December 2021 on its gene therapy trials for sickle cell disease and beta-thalassemia. The hold was due to concerns about the manufacturing process and quality control issues with their third-party vendors. This led to delays in their clinical trials and impacted their development timelines.
Outcome
Bluebird Bio conducted a detailed investigation and implemented CAPAs to address the identified deficiencies. The FDA lifted the partial clinical hold in 2022 after Bluebird Bio revamped their vendor mgt program.
How did they fix it?
Bluebird Bio implemented stricter vendor mgt protocols, including enhanced communication and oversight, which included a dedicated team to oversee vendor relationships and ensure compliance. The company also conducted regular audits and assessments to ensure the effectiveness of the corrective actions.
Lessons Learned
-
Lack of vendor oversight
-
Vendor audits are crucial
Compromised Data Integrity
Applied Therapeutics - December 2024
New Nork, NY
In December 2024, the FDA issued a warning letter to Applied Therapeutics regarding their clinical trial conduct. The FDA found during an audit that a third-party vendor contracted by Applied Therapeutics deleted electronic data in a web-based data capturing platform without consulting the company. The vendor deleted electronic data associated audit trails for subjects enrolled in their clinical study, clearly a violation of 21 CFR part 11.
Outcome
The NDA application was rejected, their stock plummeted, and ultimately, the issue rattled the executive board to the core, leading to the CEO and other executives stepping down from their roles.
How did they fix it?
The CEO suggested in her written response to the FDA that external vendors would not have access to deleting files; however, the FDA considered this response to be too vague, and highlighted the importance of managing vendor relations and operations. The company just created a new role (Feb 2025) and hired a full time VP and Head of Quality position, to drive remediation activities.
Lessons Learned
-
Sponsors hold the ultimate responsibility for the integrity and outcomes of the data.
-
It is imperative to establish controls to ensure oversight of vendor operations.
-
A robust Vendor Selection, Qualification, and Audit program is critical to support this.
Adulterated Clinical Trial Materials
ProRx LLC - December 2024
Exton, PA
On December 20, 2024, the FDA issued a warning letter to ProRx, LLC, a clinical outsourcing and testing facility, for significant deficiencies in their vendor management and oversight practices. The inspection revealed that ProRx compounded drug products using a bulk drug substance from an unregistered establishment. The FDA noted that ProRx did not have adequate procedures in place to verify the compliance of their vendors with regulatory requirements, and that lack of proper vendor oversight led to the use of the non-compliant material, ultimately compromising the sterility and safety of the drug products.
Outcome
As a result of these deficiencies, ProRx was required to take corrective actions, including ceasing sterile drug production, initiating a voluntary recall of affected products, and implementing improved quality control measures to ensure vendor compliance and product safety.
How did they fix it?
ProRx, LLC has taken several corrective actions in response to the FDA warning letter. They have ceased sterile drug production as of August 7, 2024, and initiated a voluntary recall of drug products intended or expected to be sterile due to lack of sterility assurance. ProRx has also notified the FDA of their intent to resume sterile drug production after making necessary improvements to their facility and quality control measures
Lessons Learned
As mentioned before, Sponsors are ultimately responsible for operations integrity.
Free Consultation
30 min
Free