FDA 483 - TAILSTORM HEALTH INC - July 21, 2021

This FDA Form 483 document outlines observations made during an inspection of an unnamed outsourcing facility. The inspection revealed several deficiencies related to quality control, laboratory procedures, environmental controls, and product labeling.

Specifically, the facility's written records of investigations into unexplained discrepancies were found to be incomplete, lacking conclusions and follow-up actions. Laboratory controls were cited for not establishing scientifically sound and appropriate test procedures to ensure drug products meet standards for identity, strength, quality, and purity. Furthermore, adequate equipment for controlling microorganisms, where appropriate for drug product manufacturing, processing, packing, or holding, was not provided. Finally, the container labels of the outsourcing facility's drug products were deemed deficient. These observations indicate issues with the facility's quality system, manufacturing controls, and compliance with labeling regulations.