Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 588

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 588
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 regulatory requirements and have limited capacity.

All entities involved in the preparation
of medical devices for clinical trials or commercial sale, including our existing contract manufacturers for our approved product and
product candidates, are subject to extensive regulation. Components of a finished medical device product approved for commercial sale
or used in late-stage clinical trials must be manufactured in accordance with QSR in the U.S., and similar requirements in foreign countries.
These regulations govern manufacturing processes and procedures (including record keeping) and the implementation and operation of quality
systems to control and assure the quality of investigational products and products approved for sale. Poor control of production processes
can lead to the introduction of contaminants or to inadvertent changes in the properties or stability of our approved product or product
candidates that may not be detectable in final product testing. We, our collaborators or our contract manufacturers must supply all necessary
documentation in support of any marketing application on a timely basis and must adhere to GLP and QSR regulations enforced by the FDA
and comparable foreign regulatory authorities through their facilities inspection program. The facilities and quality systems of some
or all of our collaborators and third-party contractors must pass a pre-approval inspection for compliance with the applicable regulations
as a condition of certification or regulatory approval of our product candidates or any of our other potential products. In addition,
the regulatory authorities may, at any time, audit or inspect a manufacturing facility involved with the preparation of our approved product,
product candidates or our other potential products or the associated quality systems for compliance with the regulations applicable to
the activities being conducted. We do not control the manufacturing process of, and are completely dependent on, our contract manufacturing
partners for compliance with the regulatory requirements. If these facilities do not pass a pre-approval plant inspection, certification
or regulatory approval of the products may not be granted or may be substantially delayed until any violations are corrected to the satisfaction
of the regulatory authority, if ever.

The regulatory authorities also
may, at any time following certification or approval of a product for sale, audit the manufacturing facilities of our collaborators and
third-party contractors. If any such inspection or audit identifies a failure to comply with applicable regulations or if a violation
of our product specifications or applicable regulations occurs independent of such an inspection or audit, we or the relevant regulatory
authority may require remedial measures that may be costly and/or time-consuming for us or a third party to implement, and that may include
the temporary or permanent suspension of a clinical trial or commercial sales, or the temporary or permanent closure of a