FDA 483 - Atlantis Laboratories, Inc - June 26, 2025

Atlantis Laboratories, Inc. in Conroe, TX, a contract manufacturer of OTC drugs and cosmetics, received a Form 483 with four observations. The inspection revealed significant deficiencies in the firm's quality control unit, including a lack of written procedures for change control, cleaning validation, and annual product reviews. Additionally, issues were noted with component testing, reserve sample examination, and the identification of container closures.