FDA WARNING_LETTER - ImprimisRx CA, Inc., dba ImprimisRx - March 31, 2017

On March 26, 2019, the FDA issued a Warning Letter to ImprimisRx CA, Inc., dba ImprimisRx, following a March 27-31, 2017, inspection. The inspection was prompted by a MedWatch report of a patient's death after receiving IV curcumin compounded by ImprimisRx.

The FDA found that ImprimisRx's compounded drug products failed to meet Section 503A of the FDCA conditions for exemption from CGMP, adequate directions for use, and FDA approval. Specifically, the firm compounded drugs using GHRP-2, GHRP-6, green tea extract, and artesunate, which are not eligible for 503A exemptions.

Violations included adulterated drug products due to insanitary conditions (e.g., visible stains on ISO-5 hood HEPA filters, inadequate protection studies), sub-potency (curcumin concentrations significantly lower than labeled), and contamination with Diethylene Glycol (DEG) from ungraded PEG 40 castor oil. The firm also failed to establish adequate environmental monitoring, equipment maintenance, and aseptic processing procedures, leading to CGMP violations (21 CFR 211.42(c)(10)(iv), 211.42(c)(10)(vi), 211.113(b)).

Furthermore, the ineligible drug products were un