First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy – FDA Warning Letter, Jun 14, 2019

The FDA issued a Warning Letter to First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy, following an inspection from June 5-14, 2019. The inspection revealed the firm produced drug products that failed to meet Section 503A of the FDCA conditions for exemption, specifically by not receiving valid prescriptions for individually-identified patients for products like lidocaine hydrochloride and glutathione injectable solutions. This renders these products ineligible for exemptions from CGMP, adequate labeling, and FDA approval requirements.

The firm's drug products were found to be adulterated under FDCA Section 501(a)(2)(A) due to insanitary conditions, including turbulent airflow in the ISO 5 zone, inadequate media fills, use of non-sterile cleaners, failure to sterilize mixing bars, lack of sporicidal agents in disinfection, and unconfirmed water quality. Additionally, significant CGMP violations (21 CFR Parts 210 and 211) were observed, making ineligible drug products adulterated under Section 501(a)(2)(B). These violations included failure to establish procedures for preventing microbiological contamination, lack of written standards for pyrogen removal, inadequate cleaning/disinfection systems, insufficient environmental monitoring, and failure to conduct proper laboratory testing for final specifications, objectionable microorganisms, stability, and sterility/pyrogenicity, as well as inadequate investigation of discrepancies.

The ineligible drug products were also deemed misbranded under