FDA 483 - Tiberius, Inc. - May 18, 2017

During an inspection conducted from May 15-18, 2017, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Tiberius, Inc. dba Custom Scripts Pharmacy. The inspection identified two significant observations related to the production of non-sterile drug products at their Wesley Chapel, FL facility. The first observation noted the company's use of non-pharmaceutical grade components, specifically non-purified water, in the formulation of non-sterile oral and topical drug preparations, rather than the required USP grade purified water. This practice was cited for products such as "Magic mouthwash #50" and "HQ 4% REG HC Pump." The second observation concerned the insufficient cleaning protocols for work surfaces and reusable equipment, including spatulas, when handling hazardous and highly potent drugs like antineoplastic agents (e.g., fluorouracil) and hormones (e.g., estriol). Inspectors found that cleaning methods, which involved using non-purified water, lacked documented evidence to demonstrate their effectiveness in removing and neutralizing drug residues, thereby presenting a risk of cross-contamination. These observations from the FDA 483 indicate areas where the firm’s practices deviate from regulatory expectations for drug manufacturing. Tiberius, Inc. is expected to review these findings and implement appropriate corrective actions to address the identified issues and ensure compliance with pharmaceutical quality standards.