The FDA issued a warning letter to a Texas drug compounding facility after it failed to resolve problems identified during an inspection, including serious deficiencies in sterile drug processing.
The agency issued a Form 483 to JMA Partners, doing business as Guardian Pharmacy Services, following an inspection in September and October of last year, noting the firm’s compounded drug products were not exempt from agency rules because it did not limit production to individually-identified patients with prescriptions, and it compounded drug products with grape seed oil, a component not approved by the FDA for human drugs.
In addition, the agency received adverse event reports between April and June 2017 involving at least 43 patients of the pharmacy who had experienced vision loss and impairment after injections of a drug compounded by the firm.
The FDA cited insanitary conditions for drug products that were intended to be sterile. Investigators noted that non-sterile wipes and non-sterile disinfectant were part of the facility’s disinfection process for aseptic processing areas, leading to inadequate aseptic conditions.
The firm failed to maintain sanitary conditions for processing, manufacturing, packing or storing drug products. In addition, the facility lacked a suitable system for monitoring the environmental conditions of aseptic processing areas.
The FDA said that the firm’s proposed corrective actions were inadequate because it did not commit to ending the use of non-sterile wipes or disinfectant.