FDA 483 - Promise Pharmacy, LLC - September 23, 2021

During an inspection conducted from August 30 to September 23, 2021, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Promise Pharmacy, LLC, a producer of sterile drug products in Palm Harbor, FL. The inspection identified two significant observations related to manufacturing practices and quality control. The primary violation noted was the routine use of non-pharmaceutical grade components in the formulation of various drug products, including both sterile injectable and non-sterile preparations. Numerous examples were cited, such as the use of specific lots of ingredients in compounds like TRIM Thermal, Ipamorelin/Sennorelin PF injectable, Epithalon PF injectable, and Revitalizing Eye Cream, among others. This practice raises serious concerns regarding the safety, quality, and efficacy of the compounded medications. A second critical observation involved personnel failing to maintain aseptic conditions. An investigator observed a technician touching surfaces outside the ISO 5 cleanroom area with gloved hands and then continuing with aseptic processing of an injectable drug product (LIPO-C) without properly changing or sanitizing their gloves. This lapse in aseptic technique presents a significant risk of microbial contamination to sterile products. These observations indicate potential deviations from the Federal Food, Drug, and Cosmetic Act, particularly concerning current Good Manufacturing Practices (cGMP). Promise Pharmacy, LLC is required to address these findings by developing and implementing comprehensive corrective and preventive actions to ensure the integrity, sterility, and quality of its drug products.