Company: ECIA
Filing Date: 2025-07-10
Form Type: 10-K
Source: 0001079973-25-001132
Chunk: 14

Company: ENCISION INC
Filing Date: 2025-07-10
Form: 10-K
Item: Item 1
Chunk 14
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 products, and registration, listing, medical device reporting, post-market surveillance, device tracking and other requirements
on medical devices. Failure to meet these pervasive FDA requirements or adverse FDA determinations regarding our clinical and preclinical
trials could subject us and/or our employees to injunction, prosecution, civil fines, seizure or recall of products, prohibition of sales
or suspension or withdrawal of any previously granted approvals, which could lead to a material adverse impact on our financial position
and results of operations.

The FDA regulates our quality control and manufacturing
procedures by requiring us and our contract manufacturers to demonstrate compliance with the QSR as specified in published FDA regulations.
The FDA requires manufacturers to register with the FDA, which subjects them to periodic FDA inspections of manufacturing facilities.
If violations of applicable regulations are noted during FDA inspections of our manufacturing facilities or the facilities of our contract
manufacturers, the continued marketing of our products may be adversely affected. Such regulations are subject to change and depend heavily
on administrative interpretations. In October 2015, the FDA conducted a QSR inspection of our facilities. We believe that we have the
internal resources and processes in place to be reasonably assured that we are in compliance with all applicable United States regulations
regarding the manufacture and sale of medical devices. However, if we were found not to be in compliance with the QSR, in the future,
such findings could result in a material adverse impact on our financial condition, results of operations and cash flows.

Sales of medical devices outside of the United
States are subject to United States export requirements and foreign regulatory requirements. Legal restrictions on the sale of imported
medical devices vary from country to country. The time required to obtain approval by a foreign country may be longer or shorter than
that required for FDA approval and the requirements may differ. Our Certificate of Export from the United States Department of Health
and Human Services has expired and we will seek to renew it. However, a specific foreign country in which we wish to sell our products
may not accept or continue to accept the Certificate of Export. Entry into the European Economic Area market also requires prior certification
of our quality system and product documentation. We achieved CE marking in August 2000, allowing a launch into the European marketplace.
Maintenance of the CE marking status requires annual audits of the quality system and technical documentation by our European Notified
Body, TUV Rheinland. The most recent audit was completed in February 2023.

9 

A Safety Communication was released by the FDA
on May 29