FDA 483 - Health Plus Incorporated - July 01, 2021
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An FDA inspection of Health Plus Incorporated in Chino, CA, revealed significant deficiencies in the manufacturing of their Super Colon Cleanse Laxative drug product. The firm exhibited widespread non-compliance with GMP regulations, including failures in quality unit investigations, employee training, change control, component rejection, laboratory controls, stability testing, and process validation. Several critical observations were repeats from a previous 2018 inspection, indicating persistent issues.
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