Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 228

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 228
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 our 503B facility, and to the extent we are unable to
demonstrate compliance with cGMPs and other required regulations, the government could pursue enforcement actions, the effects of
which could be costly to us and could result in adverse consequences to our business.

In August 2017, the FDA issued
a MedWatch notification regarding a curcumin emulsion and two adverse events that had been associated with the use of these emulsions
by prescribing physicians. We issued a press release on August 7, 2017, clarifying certain facts regarding the notice which outlined
our belief that the adverse events associated with the two patients occurred due to an allergic reaction caused by the products being
inappropriately administered and obtained by the prescribing physician, and our use of curcumin and excipients in our curcumin emulsion
formulation met regulatory standards required for dispensing of the curcumin emulsion. In September 2017, the FDA released a letter confirming
that the alleged misuse of certain ingredients in our curcumin emulsions was due to mislabeling by the underlying supplier and not of
our own misdoing. We no longer compound curcumin emulsion products. 

Separately, in December 2017,
we were issued a warning letter from the FDA alleging that, in its interpretation of our public communications, we had made false or
misleading claims and omitted risk and side effect information regarding certain of our ophthalmology-focused compounded medications.
We immediately performed a full review of our public communications referenced in the warning letter and responded to the FDA in January
2018; notwithstanding our continued belief that our public communications were not, in fact, false and misleading, we remained in communication
with the FDA and took steps to address the items outlined in the FDA letter. The Company received another warning letter from the FDA
in June 2022 related to our alleged marketing activities. We immediately responded to the warning letter and the FDA sent the Company
notice in January 2023 that our corrective actions appear adequate. 

In June 2019, our New Jersey-based
outsourcing facility (“NJOF”) was issued a warning letter related to an April 2017 inspection and our use of certain active
pharmaceutical ingredients in our compounded medications. During September 2020 through January 2021, our New Jersey based outsourcing
facility was inspected by the FDA (the “2020 Inspection”) and certain observations were made by the FDA in a Form 483.