Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 764

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1A
Chunk 764
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    operating restrictions or partial suspension or total shutdown of production;

    ●
    refusing or delaying our requests for 510(k) clearance, de novo authorization or PMA approval of new products or modified products;

    ●
    operating restrictions;

    ●
    withdrawal of 510(k) clearances on PMA approvals that have already been granted;

    ●
    refusal to grant export approval for our products; or

    ●
    criminal prosecution.

If any of these actions were to
occur, it would harm our reputation and cause our product sales and profitability to suffer and may prevent us from generating revenue.
Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with all applicable regulatory requirements
which could result in our failure to produce our products on a timely basis and in the required quantities, if at all.

In addition, we are required to
conduct costly post-market testing and surveillance to monitor the safety or effectiveness of our approved products, and we must comply
with medical device reporting requirements, including the reporting of adverse events and malfunctions related to our products. Later
discovery of previously unknown problems with such products, including unanticipated adverse events or adverse events of unanticipated
severity or frequency, manufacturing problems, or failure to comply with regulatory requirements such as QSR, may result in changes to
labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory
recalls, a requirement to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension of
certification or regulatory approval, product seizures, injunctions or the imposition of civil or criminal penalties which would adversely
affect our business, operating results and prospects.

41

Moreover, we may be required to
conduct costly post-market testing and surveillance to monitor the safety or effectiveness of our products in the EEA. We must comply
with medical device reporting requirements, including the reporting of adverse events and malfunctions related to our products. Later
discovery of previously unknown problems with our products, including unanticipated adverse events or adverse events of unanticipated
severity or frequency, manufacturing problems, or failure to comply with regulatory requirements may result in changes to labeling, restrictions
on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement
to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension of certification, regulatory
clearances or approvals