FDA 483 - Hospira Zagreb d.o.o. - November 22, 2019

An FDA inspection was conducted at Hospira Zagreb d.o.o. in Prigorje Brdovečko, Croatia, between November 14-15 and November 18-22, 2019. The inspection focused on the company's Drug Substance & Drug Product Manufacturing Facility. Domagoj Runac, Managing Director & Site Leader, was the recipient of the inspectional observations. The FDA Form 483 documented several observations, with one notable issue pertaining to the firm's quality control procedures. Specifically, while method descriptions for testing drug substance and drug product in-process, release, and stability samples permit the use of equivalent analytical columns, there are no written procedures in place to determine or document the equivalency of these columns. This observation indicates a potential gap in ensuring the consistent and reliable performance of analytical methods, which is critical for product quality and regulatory compliance within the Current Good Manufacturing Practices (CGMP) framework. Hospira Zagreb d.o.o. is expected to provide a comprehensive response detailing corrective and preventive actions to address the identified deficiencies.