FDA WARNING_LETTER - Tailor Made Compounding LLC - October 24, 2018

On April 1, 2020, the FDA issued a Warning Letter to Tailor Made Compounding, LLC, following an inspection from August 20 to October 24, 2018. The inspection revealed serious deficiencies in the production of sterile drug products, posing patient risks, and that drug products failed to meet Section 503A of the FDCA exemptions.

Violations included compounding drug products using bulk substances (e.g., Follistatin, GHRP-2, GHRP-6, BPC 157) 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 "ineligible drug products" are subject to FDA approval, adequate labeling, and CGMP regulations.

The facility's sterile drug products were deemed adulterated under FDCA Section 501(a)(2)(A) due to insanitary conditions, including unestablished hold times for sterilized components, use of non-sterile disinfectant in ISO 5 areas, inadequate media fills, and lack of dynamic smoke studies. Ineligible drug products were also adulterated under Section 501(a)(2)(B) due to significant CGMP violations, such as failure to establish procedures to prevent microbiological contamination (21 CFR 211.113(b)), inadequate cleaning systems