FDA WARNING_LETTER - fusion iv pharmaceuticals, inc. - March 23, 2017

On February 21, 2018, the FDA issued a Warning Letter to Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical, an outsourcing facility registered under section 503B of the FDCA since January 6, 2017. This letter followed an inspection from March 13-23, 2017, which revealed serious deficiencies in sterile drug product production and failure to meet 503B conditions.

Violations included compounding drugs using bulk substances not on the 503B bulks list or drug shortage list (e.g., GHRP-2, GHRP-6, serotonin HCl, testosterone cypionate, DMSO, DHEA, HCG, nandrolone, phosphatidylcholine, sermorelin). Labeling deficiencies were noted, such as missing "Office Use Only" for non-prescription products and absence of adverse event reporting information (www.fda.gov/medwatch and 1-800-FDA-1088). The facility also failed to submit required product reports upon initial registration (January 2017) and in June and December 2017.

Drug products were deemed adulterated under FDCA sections 501(a)(2)(A) due to insanitary conditions, including continued commercial production despite media fill failures (turbidity, particulates) and lack of media fills for an automated vial filling machine. Products were