Following a 2022 inspection, ophthalmic medicine production expert ImprimisRx received a 483 form. A year later a warning letter has been sent emphasising major issues with the facility design and operation
At the end of May, ImprimisRx NJ was issued with a warning letter for its sterile medicine production facility.
US-based ImprimisRx is focused on making sight-saving medicines. Owned by the parent company, Harrow Health, ImprimisRx has a patient specific 503A pharmacy and our FDA-Registered Outsourcing Facility.
The facility was first inspected in mid-2022, and the company has since issued a product recall and a response to the FDA's original FDA 483, the predecessor.
During the inspection, the investigators noted serious deficiencies in practices for producing drug products intended or expected to be sterile, which put patients at risk.
The letter stated: "The FDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA."
These were just some of the observations:
The letter also revealed some concerns from the Administration about drug strengths that differed from the label. The firm has previously been in hot water with the FDA over promotional materials that made false and misleading claims about one of its eyedrop therapies.
Following the recall, ImprimisRx sent a response to the FDA's Form 483.
In a review of this response, the FDA found a mixed bag: "Regarding your responses related to the insanitary conditions, some of your corrective actions appear adequate; however, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation."
A third-party consultant with relevant sterile drug processing expertise should assist you in conducting this comprehensive evaluation
- The FDA Warning Letter to ImprimisRx
These were some of the corrective actions and the FDA's response:
In conclusion, the FDA strongly recommended that the company's management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. "In particular, this review should assess your aseptic processing operations," the letter stated. "A third-party consultant with relevant sterile drug processing expertise should assist you in conducting this comprehensive evaluation."