FDA WARNING_LETTER - Promise Pharmacy, LLC - October 25, 2018

On July 29, 2019, the FDA issued a Warning Letter to Promise Pharmacy, LLC, following an inspection from October 15-25, 2018. The inspection revealed serious deficiencies in producing sterile drug products, putting patients at risk. The firm failed to meet Section 503A of the FDCA conditions, specifically by not receiving valid prescriptions for individually-identified patients for a portion of compounded drug products. This renders these products ineligible for exemptions from CGMP, adequate labeling, and FDA approval.

Violations included adulterated drug products due to insanitary conditions, such as particulates in ophthalmic solutions, an inadequate non-hazardous cleanroom with a partially located (b)(4) under a non-HEPA filtered light fixture, and poor aseptic practices (e.g., operator blocking HEPA filtered air, not wearing a beard cover, and improper movement in ISO 5 environment). Additionally, injectable bremelanotide was released with 114.3% of the labeled strength, causing it to be adulterated under section 501(c) of the FDCA. The ineligible drug products were also deemed unapproved new drugs and misbranded due to lacking adequate directions for use.

The FDA acknowledged the firm's voluntary recalls of ophthalmic solutions and all non-hazardous sterile drug products, and the temporary cessation of sterile operations. However, corrective actions for particulates and cleanroom airflow were deemed insufficient due