FDA 483 - Gold Bond Inc. - December 04, 2024

Gold Bond Inc., a repacker/relabeler in Hixson, TN, was cited for significant quality system deficiencies during an FDA inspection. Observations included the lack of an adequate Quality Unit, failure to establish written procedures for production and process controls, and inadequate procedures for equipment cleaning and maintenance, particularly concerning their Stick Spray Hand Sanitizer. The firm also distributed expired hand sanitizer product.