FDA 483 - Happy Farm Botanicals - March 15, 2024

Happy Farm Botanicals, a contract manufacturer in Hyattsville, MD, received a Form 483 for significant deficiencies in their manufacturing processes. The inspection revealed a failure to establish adequate written procedures for production and process controls, including a lack of process validation for OTC drug products like sunscreen. Additionally, the firm's equipment cleaning and maintenance procedures were found to be deficient, lacking proper cleaning validation and detailed instructions.