Department of Health and Human Services (HHS) criticizes the status of FDA’s overseas inspections

The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) conducted an audit of foreign for cause inspections of FDA drugs and issued a report criticizing FDA’s deficiencies.

HHS, a higher-level FDA organization, audited the FDA and issued a point of order to the FDA.

FDA Audits by the OIG

The OIG reviewed and audited the FDA’s foreign for cause inspections of the following drugs

• 64 inspections conducted between January 1, 2016 and March 31, 2017
• 68 inspections conducted between January 1, 2018 and March 31, 2019

As a result of the audit, the OIG found the following deficiencies

1. FDA did not always follow policies and procedures regarding foreign for cause inspections
2. FDA could not provide documentation to support that all lead investigators had completed the required training prior to conducting the inspection

OIG Recommends Improvements to FDA

The OIG issued six Recommendations to the FDA, stating that the FDA is committed to making improvements.

1. FDA should identify and implement additional ways to improve the timeliness of its foreign for-cause inspection process.
   (FDA needs to identify and implement additional methods to improve the timeliness of the foreign for-cause inspection process.)
   
2. FDA should consider streamlining the process for writing and reviewing EIRs to minimize potential delays due to unexpected events.
   (FDA should consider streamlining the process of preparing and reviewing EIRs to minimize potential delays due to unanticipated events.)
   
3. FDA should conduct an analysis of the workloards of indivisuals responsible for determining final classification, issuing warning letters, holding regulatory meetings, and address any potential issues identified by this analysis.
   (FDA should conduct a workload analysis of the individuals responsible for determining the final classification of the inspection, issuing Warning Letters, and holding Regulatory Meetings, and address any potential problems identified by this analysis.)
4. FDA should implement poliies and procedures to ensure that lead investigators assigned to inspections have completed the Level 1 Investigator Certification Process.
   (FDA needs to implement policies and procedures to ensure that lead inspectors assigned to inspections complete the Level 1 inspector certification process.)
   
5. FDA should ensure that supervisiors review investigators’ qualifications and document that they meet applicable training requirements when the investigator training records do not exist.
   (FDA must ensure that supervisors verify inspectors’ qualifications and document that they meet applicable training requirements when inspectors’ training records do not exist.)
6. FDA should review the training records of the lead invstigators that were outside the scope of the audit to verify that the documentation supports either that the investigators completed the required training courses, Level 1 Perdformance Audit, and Level 1 Investigator Certification, of that the investigators are recommended “experened investigators” by supervisors and have completed training courses equivalent to the current required training courses.
   (FDA should review the training records of the lead inspector, who was not the subject of this audit, to verify that the inspector has completed the required training courses, Level 1 performance audit, and Level 1 inspector certification, or that the inspector has been recommended by the supervisor as an “experienced inspector” and has completed a training course equivalent to the currently required training courses and that the documentation supports that the inspector has completed training courses equivalent to those currently required).

FDA Audit Report by HHS

To view the report, please here.

It is ironic that one of HHS’s points, that the FDA itself was unable to submit training records for the lead inspector, a point that the FDA frequently makes during inspections.
In the U.S., the authorities themselves seem to have a good system in that they are subject to audit and correction.

https://www.youtube.com/watch?v=zIHXobIP_vo

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