Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 137

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 137
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 it is released for distribution. If the product is subject to official release by the
FDA, the manufacturer submits samples of each lot of product to the FDA together with a release protocol showing a summary of the history
of manufacture of the lot and the results of all of the manufacturer’s tests performed on the lot. The FDA also may perform certain
confirmatory tests on lots of some products, such as viral vaccines, before releasing the lots for distribution by the manufacturer. In
addition, the FDA may conduct laboratory research related to the regulatory standards on the safety, purity, potency, and effectiveness
of biological products. Systems need to be put in place to record and evaluate adverse events reported by health care providers and patients
and to assess product complaints. An increase in severity or new adverse events can result in labeling changes or product recall. Defects
in manufacturing of commercial products can result in product recalls.

We also must comply with
the FDA’s advertising and promotion requirements, such as those related to direct-to-consumer advertising, the prohibition on promoting
products for uses or inpatient populations that are not described in the product’s approved labeling (known as “off-label
use”), industry-sponsored scientific and educational activities, and promotional activities involving the internet. Discovery of
previously unknown problems or the failure to comply with the applicable regulatory requirements may result in restrictions on the marketing
of a product or withdrawal of the product from the market as well as possible civil or criminal sanctions. Failure to comply with the
applicable U.S. requirements at any time during the product development process, approval process, or after approval may subject an applicant
or manufacturer to administrative or judicial civil or criminal sanctions and adverse publicity. FDA sanctions could include refusal to
approve pending applications, withdrawal of an approval or license revocation, clinical hold, warning or untitled letters, product recalls,
product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, mandated
corrective advertising or communications with doctors, debarment, restitution, disgorgement of profits, or civil or criminal penalties.
Any agency or judicial enforcement action could have a material adverse effect.

27

Biological product manufacturers
and other entities involved in the manufacture and distribution of approved biological products are required to register their establishments
with the FDA and certain state agencies, and they are subject to periodic unannounced inspections by the FDA and certain state agencies
for compliance with cGMPs and other laws. Accordingly, manufacturers must continue to