FDA 483 - Ambaya Gold Health Products, LLC - May 23, 2025

Ambaya Gold Health Products, LLC, a dietary supplements manufacturer in Sedona, AZ, was cited with six observations during an FDA inspection from May 19-23, 2025. The inspection revealed significant deficiencies in batch production records, master manufacturing records, and the establishment of product and component specifications, many of which were repeat observations from a previous inspection. The firm also failed to qualify suppliers by verifying certificates of analysis.