FDA 483 - Organicare Nature's Science, LLC - December 01, 2023

Organicare Nature's Science, LLC, a drug manufacturer in Austin, TX, was cited for significant deficiencies in its quality control unit, equipment cleaning procedures, and record-keeping during an FDA inspection. Observations included a lack of control over printed paper records, inadequate cleaning validation and procedures for manufacturing equipment, and the absence of individual equipment usage logs. These issues indicate a failure to maintain proper control over manufacturing processes and documentation.