Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 560

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 560
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 penalties), private litigation and/or adverse publicity and could
materially and negatively affect our operating results and business. Although a thorough privacy compliance program could mitigate the
risk of investigation and prosecution for violations of these laws and regulations, the risks cannot be entirely eliminated. Any action
against us for violation of these laws or regulations, even if we successfully defend against it, could cause us to incur significant
legal expenses and divert our management’s attention from the operation of our business. Moreover, achieving and sustaining compliance
with applicable federal, state, and foreign privacy and data security laws and regulations may prove costly.

40

If we or our suppliers fail to comply with ongoing
FDA or other foreign regulatory authority requirements, or if we experience unanticipated problems with our products, these products could
be subject to restrictions or withdrawal from the market.

Any product for which we obtain
FDA certification, clearance or approval, and the manufacturing processes, post-market surveillance, post-certification/approval clinical
data and promotional activities for such product, remain subject to continued regulatory review, oversight, requirements, and periodic
inspections by the FDA and other domestic and foreign regulatory authorities and notified bodies. For such products, we must also comply
with equivalent standards in non-U.S. countries should we choose to engage in comparable activity in those jurisdictions. These obligations
extend to our third-party suppliers as well.

In particular, we and our suppliers
are required to comply with the FDA’s QSR in the U.S. and other regulations enforced outside the United States which cover the manufacture
of our products and the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging,
storage and shipping of medical devices. Regulatory authorities, such as the FDA, and notified bodies enforce the QSR in the U.S. and
other regulations through periodic inspections. The failure by us or one of our suppliers to comply with applicable statutes and regulations
administered by the FDA, or the failure to timely and adequately respond to any adverse inspectional observations or product safety issues,
could result in, among other things, any of the following enforcement actions:

    ●
    untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;

    ●
    unanticipated expenditures to address or defend such actions;

    ●
    customer notifications for repair, replacement, refunds;

    ●
    recall, detention or seizure of our products;

    ●
    operating restrictions or partial suspension or total shutdown of production;

    ●