FDA 483 - Blendpack, Inc. - November 01, 2024

Blendpack Inc, an OTC drug manufacturer in Cleveland, TN, was cited with four observations during an FDA inspection. The inspection revealed significant deficiencies in quality control, including inadequate cGMP systems, failure to prevent microbial contamination in liquid aspirin products, lack of component identity testing, and an improperly designed and maintained deionized water system. These issues indicate a severe lack of quality oversight and control over drug manufacturing processes.