FDA 483 - ATLAS R&D Inc - September 06, 2018

ATLAS R&D Inc, an OTC drug manufacturer in Cambridge, was inspected by the FDA. The inspection revealed significant deficiencies across multiple areas of their manufacturing and quality control processes, including lack of stability testing, inadequate microbial testing validation, insufficient raw material identity testing, and poor documentation of manufacturing steps and annual product reviews. These issues indicate a lack of robust quality systems for drug product manufacturing.