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FDA Extends Remote Inspection of Non-Critical Facilities
(Thursday, January 20, 2022) FDA has increasingly relied on remote inspections of manufacturing facilities since March 2020. It announced resumption of the normal on-site inspections a few times since then and then re-paused on-site inspections due to the pandemic. Earlier this year, FDA had announced a similar pause in on-site inspections due to the spread of the omicron strain of the virus. The pause was supposed to end this week, but FDA extended it by another week in an email to a trade group. FDA inspections are an important function of the Agency, and many FDA decisions rely on the inspection reports generated by its inspectors. While FDA has claimed that it is still able to assure compliance in other ways and has claimed to not-delay more than 90% of its decisions due to lack of on-site inspections, it has been often chided by the Congress and the CBO for the lack of on-site inspections as these inspections are universally accepted as essential to assure compliance. The announced pause in inspection activities is for non-critical manufacturing operations such as at facilities found to be compliant in previous inspections, those involved in manufacture of low-risk products, and those with comprehensive submissions to the FDA indicating high level of compliance. Mission critical facilities are being inspected at the normal rate, according to FDA, although there is no independent verification of this claim. Generally, you will not hear about a delayed inspection from a manufacturing facility unless there are business consequences for that facility. The pandemic has shown that FDA’s on-site inspections are not critical for FDA’s functions. In FDA’s own words, its leadership has strongly emphasized that lack of on-site inspections did not translate to increased risk to the consumers. So, isn’t it time for FDA to make these pandemic practices as permanent policies? It makes common sense as it would reduce the burden on the inspectors while achieving the goal of assuring compliance. Perhaps in wants to but it knows that such announcement would be met with another rebuke from the CBO and other stakeholders. So, for now, we just assume that till the pandemic is announced to be over, FDA will continue reduced on-site inspections. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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