FDA 483 - THE HAIN CELESTIAL - October 20, 2023

THE HAIN CELESTIAL, a drug product manufacturer in Bell, CA, was inspected by the FDA from October 17-20, 2023. The inspection revealed a failure to thoroughly review and investigate out-of-specification viscosity stability for several OTC drug products. Additionally, the firm lacked established control procedures and process validation for various OTC drug products, indicating deficiencies in quality control and manufacturing process oversight.