Company: HROW
Filing Date: 2025-11-10
Form Type: 10-Q
Source: 0001493152-25-021562
Chunk: 128

Company: HARROW, INC.
Filing Date: 2025-11-10
Form: 10-Q
Item: Item 4
Chunk 128
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 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. Five observations made during the 2020 Inspection were considered repeat
observations from a 2017 FDA inspection. In addition, during the 2020 inspection, the FDA noted that we were compounding drugs for which
there is no change that produces a clinical difference for an individual patient, as determined by a prescribing practitioner between
a compounded drug and the comparable approved drug. We have responded to the FDA regarding all of their observations from the 2020 Inspection,
including providing documentation from prescribing clinicians that indicate a clinical difference between our compounded drugs and the
comparable approved drugs, while also committing to amend our order process to collect “medical necessity/clinical difference”
information for each order of our compounded drugs on a go-forward basis. Our pharmacy was inspected in August 2022 and received a Form
483 with several observations from the FDA. In May 2023, our pharmacy received a warning letter related to the inspection that occurred
in August 2022. The