FDA WARNING_LETTER - Town and Country Compounding and Consultation Services, LLC - August 22, 2016

The FDA issued a Warning Letter to Town & Country Compounding and Consultation Services, LLC, following an inspection from July 19 to August 22, 2016. The inspection revealed that drug products produced by the firm failed to meet the conditions of section 503A of the FDCA, and serious deficiencies in sterile drug product production practices were noted, posing patient risks.

The firm compounded drug products using GHRP-6, which is not eligible for 503A exemptions as it lacks a USP/NF monograph, is not an FDA-approved drug component, and is not on the 503A bulks list. This renders these products subject to FDA approval, adequate labeling, and CGMP regulations.

Violations included adulterated drug products due to insanitary conditions, such as exposing sterile products to less than ISO 5 air, inadequate disinfection practices (no sporicidal agent, non-sterile wipes/disinfectants, soiled plastic flaps), and cross-contamination risks from producing penicillin and other potent drugs in the same area without proper cleaning. The firm also failed to demonstrate adequate protection of ISO 5 areas.

Significant CGMP violations for ineligible drug products included failure to establish and follow procedures for preventing microbiological contamination (21 CFR 211.113(b)), inadequate cleaning/disinfection systems (21 CFR 211.42(c)(10)(v)), failure to separate