Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 229

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 229
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 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.

 30 

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