Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 218

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 218
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 FDA’s recall authority, whereby the agency can order device manufacturers to recall from the 
 market a product that is in violation of governing laws and regulations; and                     |

| ● | post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary 
 to protect the public health or to provide additional safety and effectiveness data for the device.     |

Quality Systems Regulation Requirements

Our manufacturing processes
are required to comply with the applicable portions of the QSR, which cover the methods and the facilities and controls for the design,
manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing
of finished devices intended for human use. The QSR requires that each manufacturer establish a quality systems program by which the manufacturer
monitors the manufacturing process and maintains records that show compliance with FDA regulations and the manufacturer’s written
specifications and procedures relating to the devices. The QSR also requires, among other things, maintenance of records and certain documentation,
a device master file, device history file, and complaint files. QSR compliance is necessary to receive and maintain FDA clearance or approval
to market new and existing products. As a manufacturer, we are subject to periodic scheduled or unscheduled audits or inspections by the
FDA. Our failure to maintain compliance with the QSR requirements could result in the shut-down of, or restrictions on, our manufacturing
operations and the recall or seizure of our products, which would have a material adverse effect on our business. The discovery of previously
unknown problems with any of our products, including unanticipated adverse events or adverse events of increasing severity or frequency,
whether resulting from the use of the device within the scope of its clearance or off-label by a physician in the practice of medicine,
could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls.

The FDA has broad regulatory
compliance and enforcement powers. If the FDA determines that we failed to comply with applicable regulatory requirements, it can take
a variety of compliance or enforcement actions, which may result in any of the following sanctions:

| ● | FDA untitled letters, FDA Form 483s, FDA warning letters, it has come to our attention letters, fines, 
 injunctions, consent decrees and civil penalties;                                                      |

| ● | unanticipated expenditures to address or defend such actions; |

| ● | customer notifications or repair, replacement, refunds, recall, detention or seizure of our products; |

| ● | recall, detention