FDA 483 - Universal Packaging Systems, Inc. - March 05, 2019

PakLab dba Universal Packaging Systems Inc, a device and drug repacker in Batavia, OH, was cited for significant deficiencies across its quality system during an FDA inspection. The report details widespread issues including inadequate corrective and preventive actions, unvalidated processes, poor control of non-conforming materials, and insufficient supplier and change management. These findings indicate a systemic lack of adherence to established procedures and regulatory requirements, posing a high risk to product quality and patient safety.