483
Happy Farm BotanicalsFDA 483 - Happy Farm Botanicals - March 15, 2024
Record Details
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.
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ID · a2a6e368-331e-4f7f-8469-2f4a5071741b