FDA 483 - Emilia Resources, LLC - August 09, 2019

An FDA inspection of Emilia Resources, LLC, an OTC drug manufacturer in De Kalb, MS, revealed significant deficiencies across multiple areas of their operations. The firm failed to validate manufacturing processes, lacked adequate computer system controls, and did not thoroughly investigate batch failures or ensure proper product release testing. Additionally, issues were noted with supplier qualification and the completeness of annual product reviews.