The FDA cited ZS Pharma over testing and validation issues at its API manufacturing facility in Coppell, Texas.
In a January inspection, FDA officials found the facility’s process validation was inadequate and its quality unit lacked authority to reject batches.
In a Form 483, the agency said the facility had inadequate controls for computer systems during the analytical testing process to ensure quality. The inspector also observed that the firm failed to demonstrate the reliability of one of its test methods.
In addition, the facility and equipment was not properly maintained for purity and quality assurance, and the specification of certain ingredients was not justified relative to the manufacturing process. The agency also noted inadequate validation for cleaning the facility’s equipment.
The company did not respond to request for comments.
The E2500 approach streamlines design qualification by focusing on design and verification of critical aspects of a manufacturing system that affect product quality and patient safety. Order the webinar CD/Transcript Five Case Studies Using the E2500 Approach to Validate Equipment, Utilities and Facilities and gain a clear understanding of FDA inspector expectations and how to meet those expectations for equipment, utilities and facilities validation.