FDA 483 - Zions Rx Formulations Services LLC dba Rx Formuations Serv. - December 02, 2014

The U.S. Food and Drug Administration (FDA) inspected Zions Rx Formulations Services LLC, doing business as Rx Formulations Serv., a sterile drug product manufacturer, from November 18 to December 2, 2014. The inspection identified several critical issues impacting the quality and sterility of drug products, many of which were repeat observations from a previous inspection.

Key observations included significant deficiencies in environmental monitoring within aseptic processing areas. The firm failed to routinely monitor viable and non-viable particulates in ISO Class 5 and 7 cleanroom environments during active drug production and lacked routine personnel monitoring after each lot of aseptically processed products. Additionally, protective apparel was deemed inadequate; personnel did not sufficiently cover exposed skin (face, neck) in cleanrooms, nor did they use sterile over sleeves in ISO Class 5 Hoods.

Another major concern was the absence of a written stability testing program. The firm assigned beyond-use or expiration dates to drug products, such as B-12 for injection, based on literature rather than actual product-specific stability studies. These findings highlight the company's need to implement robust corrective actions to ensure compliance with Good Manufacturing Practices and safeguard drug product quality and sterility.