FDA 483 - Dyno Manufacturing, Inc - November 01, 2024

An FDA inspection of Dyno Manufacturing Inc. in Madison, IL, revealed significant deficiencies in the manufacturing of liquid OTC hand sanitizer and antibacterial soap drug products. The firm lacked an approved stability testing program and had not conducted stability studies to support product expiration dates. Additionally, the inspection found failures in establishing written procedures for production and process controls, including incomplete process validation and equipment qualifications, and issues with the quality control unit's responsibilities, such as self-review of test results and uncompleted annual product reviews.