Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 190

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 190
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compliance with applicable federal, state, and local statutes and regulations requires the expenditure of substantial time and financial
resources. Rigorous and extensive FDA regulation of biological products continues after approval, particularly with respect to cGMP. We
will rely, and expect to continue to rely, on third parties for the production of clinical and commercial quantities of any products
that we may commercialize. Manufacturers of our products are required to comply with applicable requirements in the cGMP regulations,
including quality control and quality assurance and maintenance of records and documentation.

Following approval,
the manufacturing facilities are subject to inspections by the FDA, and such inspections may result in an issuance of FDA Form 483
deficiency observations, untitled letter, or a warning letter, which can lead to plant shutdown and other more serious penalties and
fines. Prior to the institution of any manufacturing changes, a determination needs to be made regarding whether FDA approval is required
in advance. If not done in accordance with FDA expectations, the FDA may restrict supply and may take further action. Product reports
are required to be submitted annually. Other post-approval requirements applicable to biological products include reporting of cGMP deviations
that may affect the identity, potency, purity, and overall safety of a distributed product, recordkeeping requirements, reporting of
adverse events, reporting updated safety and efficacy information, and complying with electronic record and signature requirements.

After a BLA is approved,
the product also may be subject to official lot release. As part of the manufacturing process, the manufacturer is required to perform
certain tests on each lot of the product before 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