Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 563

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 563
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 applicable regulations. Product defects or other errors
may occur in the future.

Depending on the corrective action
we take to redress a product’s deficiencies or defects, the FDA may require, or we may decide, that we will need to obtain new clearances
or approvals for the device before we may market or distribute the corrected device. Seeking such clearances or approvals may delay our
ability to replace the recalled devices in a timely manner. Moreover, if we do not adequately address problems associated with our devices,
we may face additional regulatory enforcement action, including FDA warning letters, product seizure, injunctions, administrative penalties
or civil or criminal fines.

Companies are required to maintain
certain records of recalls and corrections, even if they are not reportable to the FDA. We may initiate voluntary withdrawals or corrections
for our products in the future that we determine do not require notification of the FDA. If the FDA disagrees with our determinations,
it could require us to report those actions as recalls and we may be subject to enforcement action. A future recall announcement could
harm our reputation with customers, potentially lead to product liability claims against us and negatively affect our sales. Any corrective
action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital,
will distract management from operating our business and may harm our reputation and financial results.

42

All manufacturers placing medical
devices on the market in the EEA are legally bound to report to the relevant competent authorities (a) any serious incident involving
devices made available on the EEA market, except expected side-effects which are clearly documented in the product information and quantified
in the technical documentation and are subject to trend reporting, and (b) any field safety corrective action in respect of devices made
available on the EEA market, including any field safety corrective action undertaken in a third country in relation to a device which
is also legally made available on the EEA market, if the reason for the field safety corrective action is not limited to the device made
available in the third country. Reports should be submitted through the electronic system set up and managed by the European Commission
in collaboration with EEA countries. Reports of serious incidents will be automatically transmitted to the competent authority of the
EEA country in which the incident occurred and reports on field safety corrections actions will be automatically transmitted to the competent
authority of the EEA country in which the field safety corrective action is being or is to be undertaken and the EEA country in