FDA 483 - New Vitalis Pharmacy LLC - September 07, 2018

An FDA inspection conducted at New Vitalis Pharmacy LLC (dba New Vitalis Pharmacy) from August 27 to September 7, 2018, identified three significant observations related to the production of sterile and non-sterile drug products. The primary concerns revolve around the quality control and manufacturing practices for drug products.Firstly, the firm was cited for releasing Testosterone Cypionate 200MG/ML in Grapeseed Oil (lots AL-07192018@906 and AL-08072018@901) using a food-grade Grapeseed oil labeled as a "Dietary Supplement." This raises concerns about the suitability and pharmaceutical quality of components used in drug manufacturing, potentially affecting the product's strength, purity, or quality.Secondly, the inspection noted inadequate visual inspection procedures for finished drug products prior to distribution. Despite claims of 100% visual checks for sterile injectable vials, the firm did not employ standard tools like black or white boxes or additional lighting to properly identify visible particulates, cloudiness, or discoloration. This deficiency could lead to the release of substandard products.Finally, non-sterile wipes were observed being used for routine cleaning of ISO 5 hoods in the ISO 7 cleanroom, which is critical for maintaining a sterile environment. This practice compromises environmental control and poses a risk to the sterility of drug products.These observations indicate deviations from current Good Manufacturing Practices (cGMP). New Vitalis Pharmacy is expected to promptly investigate these issues and implement comprehensive corrective actions to ensure the quality, purity, and strength of its drug products, enhance its visual inspection processes, and establish appropriate sterile cleaning protocols.