Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 24

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 24
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 Jersey are governed by Section 503A of the FDCA, and our New Jersey based outsourcing facility
is governed by Section 503B of the FDCA.

On July 30, 2020, the FDA issued
a notice for comments related to certain bulk drug substances to be removed from the 503B Bulk’s List (or Category 1 List). Included
in this notice for comment were certain bulk drug substances which we currently use in some of our compounded products. In the event
one or more of these bulk substances are ultimately removed from the Category 1 List, we intend to utilize commercially available versions
of these substances or similar active pharmaceutical ingredients as replacements of the bulk powders contained in our sterile products.
Nonetheless, if all or some of the bulk drug substances we use are removed from the 503B Bulk’s List, this may result in a disruption
in our operations, revenues and cash flows.

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From March 2024 through
April 2024, NJOF was inspected by the FDA (the “2024 Inspection”), and the FDA issued a Form 483 with five observations.
Following the 2024 Inspection, NJOF voluntarily recalled certain products in coordination with the FDA. Since the 2024 Inspection,
NJOF has provided regular updates to the FDA regarding its remediation activities and other commitments, including providing the FDA
with a comprehensive update in February 2025. Since January 2025, we have engaged in separate but related discussions with the
federal government regarding the NJOF quality system and the 2024 Inspection. In support of our ongoing commitment to compliance, we
engaged an independent third-party current good manufacturing practices (cGMP) expert to review our NJOF operations and to recommend
actions to improve our compliance and quality activities (the “cGMP Expert Engagement”). The cGMP Expert Engagement is
ongoing, and we expect to regularly update the FDA regarding our compliance and quality activities. To the extent NJOF is unable to
comply with cGMPs, the FDA could pursue administrative or judicial enforcement actions against NJOF, including, but not limited to,
issuing additional warning letters or seeking injunctive relief. Any of these actions could be costly and result in material adverse
consequences to our business, performance, prospects, value, financial condition, and results of operations. See Part I, Item 1A.
“Risk Factors – We have been in discussions with the federal government regarding past FDA inspections of our