FDA 483 - Avalon Packaging, Inc. - December 21, 2020

Avalon Packaging, a dietary supplement manufacturer in Orem, UT, received a Form 483 with six observations during an FDA inspection. The inspection revealed significant deficiencies in quality control operations, including a failure to establish and adhere to specifications for components, in-process materials, and finished products. Many of these issues were repeat observations from a previous inspection, indicating a persistent lack of compliance with manufacturing regulations.