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

During an inspection from September 4-6, 2018, the FDA identified significant manufacturing deficiencies at ATLAS R&D Inc, an Over-The-Counter (OTC) drug manufacturer. The observations, detailed in a Form FDA 483, indicate a lack of adherence to federal manufacturing regulations for drug products. Key issues included the absence of a written program to assess drug product stability, with insufficient data to support product expiration dates. The firm also failed to ensure adequate microbial testing, as analytical methods for detecting objectionable microorganisms were not properly validated. Furthermore, component quality control was lacking; the company accepted supplier analyses without conducting essential identity testing on raw materials or establishing acceptance specifications. Procedural gaps were noted, such as the absence of a second-person verification for critical weighing steps during manufacturing and the failure to conduct annual product quality reviews. Additionally, core manufacturing processes for their OTC drug product were not validated or adequately documented, lacking established parameters and uniformity studies. Batch production records were found deficient, missing documentation of key manufacturing steps like mixing speeds and times. ATLAS R&D Inc is required to address these observations by implementing comprehensive corrective actions to ensure their manufacturing, testing, and control procedures comply with FDA requirements, thereby safeguarding product quality and patient safety.