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Regulatory Focus™ > News Articles > 2020 > 1 > OAI Classifications for Drug, Device Facilities Decline Sharply Over Last 5 Years, FDA Data Show

OAI Classifications for Drug, Device Facilities Decline Sharply Over Last 5 Years, FDA Data Show

Posted 20 January 2020 | By Zachary Brennan 

OAI Classifications for Drug, Device Facilities Decline Sharply Over Last 5 Years, FDA Data Show

As the spotlight on foreign drug and medical device facilities brightens because of impurity concerns and a lack of US Food and Drug Administration (FDA) staff abroad, the total number of Official Action Indicated (OAI) classifications continued to fall in 2019, and US-based facilities still saw the lion’s share.

A look into FDA’s inspection classification database for the drug, device and biologic centers reveals how China and India’s share of the overall OAI classifications total has remained relatively steady over the past five years, while the US has seen a declining number of such classifications.

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And here’s a look below at the data on OAI classifications from FDA’s data dashboard over the last decade for just drugs, devices and biologics (the totals are a little bit different between FDA’s inspection classification database and the data dashboard but both make clear that inspections conducted by states, pre-approval inspections, mammography facility inspections, inspections waiting for a final enforcement action and inspections of nonclinical labs are not included). 

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To provide a sense for how uncommon OAI classifications are, here's a look at the comparison between all three classifications (described in depth below).
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How the classification system works: After an inspection of a manufacturing site, FDA determines if the areas evaluated comply with applicable laws and regulations. FDA and the Inspection Classification Database classify the inspection by each project area with one of three classifications:
  • No Action Indicated (NAI), which makes up the majority of device and biologic inspection results, and means no objectionable conditions or practices were found during the inspection (or the objectionable conditions found do not justify further regulatory action);
  • Voluntary Action Indicated (VAI), which makes up the majority of drug inspections, and means objectionable conditions or practices were found but the agency is not prepared to take or recommend any administrative or regulatory action; or
  • Official Action Indicated (OAI) which means regulatory and/or administrative actions will be recommended.
According to former FDA officials, VAI inspections “may lead to inspection follow-up or more frequent re-inspections, but typically no additional compliance actions. OAI inspections often lead to compliance actions for food and postmarket medical products and recommendations to withhold product approval for preapproval inspections.”

After FDA has classified an inspection as NAI or VAI, it provides the firm with a copy of the Establishment Inspection Report (EIR). But for OAI inspections, the EIR is not received until the relevant compliance action has been undertaken or the matter has otherwise been closed, the lawyers noted.

And although it can be difficult to generalize about why there has been a declining number of OAI classifications overall, the decline may be a positive sign that the drug and device industries are stepping up their compliance, or a sign that FDA has held back its enforcement powers in recent years (or both).

On the device side, CDRH warning letters have declined from 81 in fiscal year 2015 to just nine in 2019, although officials have suggested that there could be an uptick in warning letters this year.

Part of the reason for OAI classifications occurring more frequently in the US than any other country is because it’s easier for the inspectors to access these sites. With just 12 foreign-based drug inspectors currently, FDA says 90% of its foreign inspections are conducted by US-based inspectors who have to fly into the country for the inspection.

Janet Woodcock, director of CDER, testified last month before the House Energy & Commerce subcommittee on how FDA needs to hire about 50 new inspectors. Mary Denigan-Macauley, director of health care at GAO, also said at the hearing that FDA routinely gives foreign drug manufacturers significant advanced notice of overseas inspections, while the agency does not announce many domestic inspections.

Meanwhile, plans at FDA to create a quality management maturity rating system for individual drug manufacturing facilities based on objective indicators is being considered.

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