FDA EIR - Woodstock Sterile Solutions Inc - May 23, 2019

An FDA inspection was conducted at Catalent Pharma Solutions, LLC in Woodstock, IL, from May 21 to May 23, 2019. This comprehensive review, part of the Infant Formula and Medical Foods Programs, assessed the company’s adherence to regulatory frameworks, including 21 CFR Part 117 for current Good Manufacturing Practices (cGMPs), hazard analysis, and risk-based preventive controls for human foods. The inspection focused on the firm’s contract filling and packaging operations for an infant formula. Notably, the inspection concluded without any formal objectionable conditions being observed or a Form FDA 483 being issued. However, two items were discussed with management. First, it was noted that the water used for Clean-In-Place (CIP) processes and a specific manufacturing operation was not tested for radiological contaminants. Management clarified this water source and its application, indicating it was not directly used in product formulation. Second, a pressure transmitter was found to be slightly out of tolerance by approximately 1.4 psig during its most recent calibration. Management considered this an isolated deviation, indicating they would monitor the equipment's performance without immediate replacement or adjustment to the calibration schedule, unless the anomaly recurs. No specific formal regulatory actions were required as a direct result of this inspection.