FDA 483 - Alkaline Corp. - August 16, 2022

Alkaline Corp. in Eatontown, NJ, a medical device manufacturer, was cited for two significant observations during an FDA inspection. The firm failed to establish procedures for design control, leading to undocumented design changes and unapproved design validation records for their Morrow Brown Disposable Allergy Test Needles. Additionally, the sterilization process for these needles lacked adequate validation, specifically regarding the placement of biological indicators.