FDA WARNING_LETTER - Right Value Drug Stores, LLC dba Carie Boyd Pharmaceuticals - June 21, 2024

On December 17, 2024, the FDA issued Warning Letter WL #694687 to Right Value Drug Stores, LLC dba Carie Boyd Pharmaceuticals, an outsourcing facility registered under section 503B of the FDCA. The letter followed an inspection from May 28 to June 21, 2024, which revealed significant deficiencies.

The facility failed to meet 503B conditions, specifically by not including the quantity or proportion of inactive ingredients on labels for products like Ketoconazole 2% Cream and Testosterone Cypionate injections. This renders their compounded drugs ineligible for exemptions from FDA approval, adequate directions for use labeling, and Drug Supply Chain Security Act requirements.

The FDA also identified adulterated drug products due to insanitary conditions and CGMP violations. Insanitary conditions included inadequate smoke studies showing disrupted unidirectional airflow in the ISO 5 area and media fills not performed under challenging conditions. CGMP violations cited failure to follow procedures to prevent microbiological contamination (21 CFR 211.113(b)), inadequate investigation of discrepancies (21 CFR 211.192), improper cleaning/sterilization of container closures (21 CFR 211.94(c)), inadequate equipment cleaning/maintenance procedures (21 CFR 211.67(b)), and insufficient environmental controls (21 CFR 211.46(b)).