Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 49

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 49
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 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 in our laminar airflow hoods had been redone
to satisfy FDA requirements, however, we did not provide the FDA with supporting documentation (such as smoke study protocol, updated
detailed report and/or videos). We have responded to this warning letter and provided the FDA with additional information requested.

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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