FDA 483 - Nature's Innovation, Inc. - May 14, 2019

An FDA inspection of Nature's Innovation, Inc., an OTC homeopathic manufacturer in Buford, GA, revealed significant deficiencies across its manufacturing and quality control processes. The firm failed to perform essential microbiological and identity testing, investigate product complaints and discrepancies, and maintain adequate records for product quality reviews and distribution. Additionally, critical equipment was not properly qualified or calibrated, and manufacturing processes lacked validation and complete batch records.