FDA WARNING_LETTER - JMA Partners - October 21, 2016

On September 12, 2016, to October 21, 2016, the FDA inspected JMA Partners, Inc. dba Guardian Pharmacy Services in Dallas, Texas. The inspection revealed that the firm produced drug products that failed to meet the conditions of section 503A of the FDCA for exemption from certain provisions. Additionally, serious deficiencies in sterile drug product production practices were noted, posing patient risks. The FDA received adverse event reports on April 5, 2017, and June 1, 2017, concerning at least 43 patients who experienced vision impairment and loss after receiving intravitreal injections of a drug compounded by the firm containing triamcinolone and moxifloxacin.

The firm failed to meet Section 503A conditions by not receiving valid prescriptions for individually-identified patients for a portion of products and by compounding with grape seed oil, which is not a USP/NF monograph substance, an FDA-approved drug component, or on the 503A bulks list. These "ineligible drug products" are subject to FDA approval, adequate labeling, and CGMP requirements.

Violations included adulterated drug products due to insanitary conditions (e.g., non-sterile wipes/disinfectant, particle board laminar flow hood) and significant CGMP violations: inadequate cleaning/disinfection systems (21 CFR 211.42