Company: HROW
Filing Date: 2025-11-10
Form Type: 10-Q
Source: 0001493152-25-021562
Chunk: 75

Company: HARROW, INC.
Filing Date: 2025-11-10
Form: 10-Q
Item: Item 1
Chunk 75
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 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. 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. Since January
2025, we engaged in separate but related discussions with the federal government regarding the NJOF quality system and the 2024 Inspection.
NJOF voluntarily recalled certain products and provided regular updates to the FDA regarding its remediation activities and other commitments,
including Project Beagle. The government has notified us that these discussions are now closed. Future regulatory actions could increase
scrutiny and could create negative publicity on us as a company. As part of our commitment to actively work with regulators, at times,
we have become aware of concerns related to certain formulations, and as a result, discontinued compounding certain drug formulations
in an attempt to help mitigate potential regulatory risk. For other reasons, including, but not limited to, the following, physicians
may be unwilling to prescribe or patients may be unwilling to use our compounded formulations: legal prohibitions on our ability to discuss
the efficacy or safety of our formulations with potential users to the extent applicable data is available; our pharmacy operations are
primarily operating on a cash-pay basis and reimbursement may or may not be available from third-party payors, including the government
Medicare and Medicaid programs; and certain formulations are not required to