ImprimisRx NJ
FDA issued a warning letter to ImprimisRx NJ (President John Saharek) following a July–August 2022 inspection that revealed serious insanitary conditions in sterile drug compounding operations and repeated release of subpotent Timolol-Latanoprost ophthalmic drops. The facility's drug products were deemed adulterated under FDCA sections 501(a)(2)(A) and 501(c) due to insanitary cleanroom conditions and label-strength discrepancies, and misbranded under section 502(a) for false labeling. This was a repeat issue, as subpotency of the same product was also identified during a 2019 inspection. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (1)
the root cause of the Latanoprost failures was determined to be method.
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations.
FDA strongly recommends that your 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. A third party consultant with relevant sterile drug processing expertise should assist you in conducting this comprehensive evaluation.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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