FDA Continued Increased Remote Inspections in 2021
(Thursday, May 5, 2022)
An FDA annual report on compliance inspections released this week confirms that the practices of remote inspections and use of alternate ways to monitor compliance by FDA inspectors, that became necessary during the peak of the pandemic, stayed prominent even as the pandemic waned. Remote inspections are frowned upon by the government watch dogs such as the Government Accountability Office (GAO), who believe that the traditional audit process where FDA inspectors physically inspect the facility to verify compliance, are more suitable than remote inspections and review of documents. However, FDA has insisted that it can adequately monitor compliance and better manage its resources by using alternate sources for compliance related information and targeted inspections of facilities. The CDER compliance report emphasizes that FDA was able to effectively monitor compliance at regulated facilities by using “alternate measures”. The report lists several inspection activities conducted by the Office of Compliance in 2021 to monitor compounding facilities, GMP facilities, clinical trial sites, and import of regulated products, which, per it’s matrices, were successful in preventing non-compliance. It is hard to evaluate from the report the full extent of the compliance inspections conducted by this office as it does not list the total number of facilities inspected or the percent of remote versus on-site inspection. For example, it lists that FDA issued 149 Warning Letters in 2021 but does not describe what percent of facilities were issued such letters or what were the major findings of these inspections. It mentions that FDA conducted 47 fully remote clinical trial compliance assessments, basically GCP audits, but does not tell that these 47 represent what fraction of all the GCP inspections conducted. Without such comparative data it is hard to evaluate the efficiency of this office or the utility of the various tools in catching most of the non-compliance facilities, as would be expected. It should not be surprising that FDA continues to use the practices that became more common during the pandemic, but it would be good know what percent of FDA activities have moved to the pre-pandemic practices and what have changed for good. That way, the industry will be truly able to understand and comment on the performance of the Office of Compliance.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC