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FDA Presses Pause on Domestic and Foreign Inspections for all FDA-Regulated Products Due To COVID-19 Concerns

Client Alert | 1 min read | 03.20.20

In response to the recent COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) has temporarily paused all domestic and international on-site inspections not deemed “mission-critical.”

On Wednesday, March 18th, FDA Commissioner Stephen Hahn announced that the Agency would temporarily halt domestic inspections not deemed “mission-critical,” citing concerns for the health and well-being of its staff.  These are inspections the FDA conducts every few years based on a risk analysis. Instead, during this interim period, the Agency will evaluate alternative ways to conduct inspectional work to ensure the safety of the firm and the FDA staff such as evaluating records in lieu of conducting onsite inspections.  It is important to note that domestic for-cause inspections will proceed if considered “mission-critical.”

Similarly, on March 10th, the Agency announced that it would temporarily scale back foreign inspections, through April, not deemed “mission-critical.”  The FDA cited a number of factors including State Department travel advisories, CDC travel recommendations, and other guidance.  FDA stated that in the interim, it would employ additional tools to ensure the safety of imported products, including denying entry of unsafe products, physical inspection, product sampling at the border, and reviewing the manufacturer’s compliance history, among others.  As is the case with domestic inspections, inspections of foreign facilities deemed “mission critical” will continue on a case-by-case basis.

FDA encourages the industry to “own” safety and quality during this unprecedented time, and adhere to existing reporting and cGMP requirements pertaining to manufacturing, sanitation, and process controls. 

In short, the spring on-site inspection that your business has been expecting probably won’t happen.  Domestic and foreign manufacturers, nonetheless, should continue adhering to all cGMP and reporting requirements, as FDA indicated it may rely on such reports to determine manufacturer compliance.  In addition, we expect that the FDA will extend its suspension of non-critical foreign inspections beyond April.

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Client Alert | 1 min read | 07.08.26

CAS Board Publishes Final Rule Rescinding CAS 404, 408, 409, and 4117

As part of its ongoing effort to conform the Cost Accounting Standards (“CAS”) to generally accepted accounting principles (“GAAP”), the CAS Board published a final rule rescinding CAS 408 (Accounting for costs of compensated personal absence) and CAS 411 (Accounting for acquisition costs of material).  The CAS Board also rescinded CAS 404 (Capitalization of tangible assets) and CAS 409 (Depreciation of tangible capital assets) but retained certain requirements of CAS 404 and 409, which will be located in new paragraphs of CAS 405 (Accounting for unallowable costs).  Specifically, the CAS Board retained the requirements currently located at CAS 404-50(d)(1), CAS 409-50(e)(5), CAS 409-50(j)(1), and CAS 409-50(j)(4), which the CAS Board explained are necessary to protect the Government’s interests.  Otherwise, the CAS Board determined that the requirements of CAS 404, 408, 409, and 411 overlapped with GAAP such that GAAP “may be applied reasonably as a substitute for CAS to support contract cost and pricing.”...

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