Triad Rx, Inc – FDA Warning Letter, Jul 21, 2017

On February 5, 2019, the FDA issued a Warning Letter to Triad Rx, Inc. following an inspection from July 17-21, 2017. The inspection revealed that Triad Rx, Inc. produced drug products that failed to meet the conditions for exemption under section 503A of the FDCA, specifically regarding sterile drug product production and the use of bulk drug substances.

Violations included compounding drug products using GHRP-2, GHRP-6, and chromium picolinate, which are not eligible for 503A exemptions as they lack USP/NF monographs, are not FDA-approved drug components, and are not on the 503A bulks list. These products are considered unapproved new drugs and misbranded.

Furthermore, the facility exhibited insanitary conditions, leading to adulterated drug products under section 501(a)(2)(A) of the FDCA. Deficiencies included: partially stoppered vials exposed to sub-ISO 5 air; personnel blocking first pass air; improper (b)(4) testing; difficult-to-clean surfaces in ISO areas; inadequate media fills; re-use of non-sterile IPA bottles; exposed hands/wrists in ISO 5 areas; non-sterile cleaning pads; personnel touching non-ISO 5 surfaces with gloved hands; un-disinfected equipment entering ISO 5; and inadequate sporicidal