Company: HROW
Filing Date: 2025-08-11
Form Type: 10-Q
Source: 0001641172-25-022980
Chunk: 87

Company: HARROW, INC.
Filing Date: 2025-08-11
Form: 10-Q
Item: Item 2
Chunk 87
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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 warning letter indicated that our corrective actions from the inspection
had appeared to be adequate; however, the FDA could not fully evaluate the adequacy of our actions because we did not include sufficient
information or supporting documentation. As an example, we stated that smoke studies related to airflow