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Compliance In Focus
Posted by Katelyn Weed on Tue, Jul 16, 2019

2018 FDA Warning Letters: Common Deficiencies

Each year, the FDA publishes its Bioresearch Monitoring (BIMO) metric findings to provideWarning_LP insight on audit trends and significant violations. The BIMO program’s inspectional data includes Clinical Investigative Sites, Institutional Review Boards (IRBs), Sponsors/Monitors, Contract Research Organizations CROs), Bioequivalence, and Good Laboratory Practice Audits.

After conducting an ins pection, the FDA provides the classification of the inspection to reflect the compliance status based on observations noted. An Official Action Indicated (OAI) occurs when regulatory action is needed to address non-compliant, objectionable conditions or practices observed. A Voluntary Action Indicated (VAI) occurs when objectionable conditions or practices are observed but do not require immediate regulatory action. No Action Indicated (NAI) occurs when no objectionable practices or conditions were observed during the inspection.

Earlier this year, we published the top findings of previous years and the preliminary trends seen in 2018’s warning letters. Now, the 2018 BIMO metric results are in!

The 2018 findings are not new and should not come as a surprise. In fact, many of the common deficiencies identified during the 2018 BIMO Inspections have been repeatedly found in the previous years’ BIMO metric findings.

Clinical Investigative Site Inspections continued to be the most frequent type of Inspection in 2018. Of the 904 Clinical Investigators inspected, 72% resulted in an NAI classification, 27% resulted in a VAI classification, and 1% resulted in OAI classification.

The most common Clinical Investigator deficiencies identified in the FDA Form 483 Warning Letters included:

  • Failure to conduct the investigator in accordance with the investigator statement or agreement, investigational plan, and applicable regulations
  • Failure complying to the FDA 1572 requirements*
  • Failure to record adequate case history and subject records*
  • Failure to provide adequate accountability and disposition records for the investigational product
  • Failure to protect the rights and safety of clinical trial subjects, specifically failing to obtain informed consent in accordance with 21 CFR Part 50
*Denotes deficiencies not previously amongst the most commonly cited in the past three years

For Institutional Review Boards, a total of 163 inspections were conducted in 2018, with 75% of inspections resulting in NAI classification, 24% resulting in VAI classification, and 1% resulting in OAI classification.

Common IRB deficiencies noted in the FDA Form 483 Warning Letters included:

  • Failure to provide adequate meeting minutes and membership rosters
  • Failure to conduct adequate initial and continuing review of research
  • Failure to maintain adequate written procedures for reporting non-compliance, suspension or termination*
  • Quorum issues, which is related to the minimum number of members required to conduct a meeting

*Denotes deficiencies not previously amongst the most commonly cited in the past three years

Of the 175 Sponsor, Monitor, CRO, and Sponsor-Investigator inspections, 74% resulted in NAI classification, 22% resulted in VAI classification, and 4% resulted in OAI classification.

  • Failure to adequately monitor the study
  • Failure to bring the Clinical Investigators into compliance and ensure compliance with the protocol
  • Failure to secure compliance of investigators
  • Failure to terminate an investigator’s participation in an investigation*
  • Failure to conduct adequate investigational product accountability
  • Failure to communicate significant new information or new adverse events to the FDA/IRB/investigators*

*Denotes deficiencies not previously amongst the most commonly cited in the past three years

These lists of common deficiencies, especially the newly noted findings, provide IMARC Research, Inc. with a better understanding of current non-compliant trends. The deficiencies that were not previously amongst the most commonly cited in the past three years may indicate the direction of the FDA’s inspection focus.

IMARC utilizes this information when serving as compliance partners to ensure that investigations follow study protocol and current FDA guidelines.

Does your company have regulatory weaknesses? If so, in what areas?

What would your inspection classification be if inspected?

FDA Inspections

Topics: BIMO Metrics, FDA Warning Letters

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