Happy Farm Botanicals – FDA 483, Mar 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.
ID · a2a6e368-331e-4f7f-8469-2f4a5071741b
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