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, resulted in the issuance of an FDA Form 483, detailing three significant observations. The company, a producer of sterile and non-sterile drug products, was cited for deficiencies related to drug product quality and manufacturing controls. The primary issue involved the production of Testosterone Cypionate 200MG/ML in Grapeseed Oil using an apparent food-grade grapeseed oil, labeled as a "Dietary Supplement," which may compromise the drug's quality, strength, or purity. Additionally, the firm's visual inspection process for finished drug products was found inadequate; despite claims of 100% checks, proper lighting and background tools were not utilized to detect particulates or other contaminants in sterile vials prior to distribution. Finally, non-sterile wipes were observed being used for routine cleaning of ISO 5 hoods, which are critical sterile environments, posing a contamination risk. These observations highlight potential non-compliance with fundamental quality and manufacturing standards. New Vitalis Pharmacy is expected to promptly address these findings by investigating the root causes and implementing comprehensive corrective actions to ensure product quality, safety, and compliance with regulatory expectations for drug manufacturing.