FDA 483 - Wells Pharmacy Network LLC - June 22, 2018

During an inspection conducted from June 18 to June 22, 2018, Wells Pharmacy Network LLC, a preparer of sterile and non-sterile drug products, received an FDA Form 483. This document outlined a significant observation regarding the company's manufacturing practices, indicating potential issues under the federal food, drug, and cosmetic act and related regulations. Specifically, the inspection revealed that Wells Pharmacy Network LLC utilized a component lacking pharmaceutical-grade documentation in the formulation of various drug products. The observation detailed the use of a non-pharmaceutical grade ingredient to prepare a foundational liquid sub-formula. This sub-formula was subsequently incorporated into several critical drug products, including prednisolone oral suspensions, hyaluronic acid sodium salt topical gels, and oxytocin nasal sprays. Despite being listed as USP grade on internal worksheets, the company was unable to provide verifiable documentation confirming the pharmaceutical suitability or USP compliance of this component. This finding indicates a potential lapse in quality control and adherence to Good Manufacturing Practices. While an FDA 483 represents initial inspectional observations, it necessitates a thorough review and implementation of corrective and preventive actions by Wells Pharmacy Network LLC to address the identified issues and ensure all components meet appropriate quality standards for pharmaceutical use.