FDA 483 - Health Plus Incorporated - April 21, 2023

Health Plus Inc. in Chino, CA, an OTC drug manufacturer, received a Form FDA 483 with 10 observations. The inspection revealed significant deficiencies in quality control, including failures to qualify third-party vendors and contract testing laboratories, inadequate investigation of complaints and OOS results, and a lack of annual product reviews. Additionally, the firm failed to complete process and cleaning validations, maintain complete batch records, and ensure proper control procedures for manufacturing and equipment.