FDA WARNING_LETTER - Imprimis NJOF, LLC - July 10, 2017

On June 7, 2019, the FDA issued a Warning Letter to Imprimis NJOF, LLC, an outsourcing facility registered under section 503B of the FDCA. The letter followed an inspection from April 24 to July 10, 2017, which revealed serious deficiencies in sterile drug product production and failure to meet 503B conditions, putting patients at risk.

Violations included compounding drug products with gatifloxacin, which is not on the 503B bulks list or drug shortage list, thus making these products ineligible for 503B exemptions. The firm also failed to submit complete drug product reports for June 2017 and did not submit adverse event reports within the required 15 calendar days, specifically for a bilateral hemorrhagic occlusive retinal vasculitis (HORV) case.

Furthermore, the FDA cited multiple Current Good Manufacturing Practice (CGMP) violations, rendering drug products adulterated. These included inadequate environmental monitoring, insufficient testing of incoming materials, a deficient quality control unit, and failure to thoroughly investigate discrepancies. An analysis of their triamcinolone moxifloxacin injectable product found the presence of an unapproved antioxidant. The compounded drugs were also deemed unapproved new drugs and misbranded due to lack of adequate directions for use.

The FDA found the firm's corrective actions to the Form FDA 483 largely deficient, particularly regarding environmental