Health Plus Inc. – FDA Warning Letter, Jul 1, 2021

The FDA inspected Health Plus Inc. (FEI 2027164) in Chino, California, from June 23 to July 1, 2021, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug product adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Inadequate handling of returned drugs (21 CFR 211.204):** The firm failed to inspect, investigate, and test returned products before redistribution. They combined returned capsules from various lots, assigned new lot numbers and unsupported three-year shelf lives, exceeding original expiration dates by up to 18 months, without stability data or testing. 2. **Failure to establish adequate production and process control procedures (21 CFR 211.100(a)):** The firm did not adequately validate the manufacturing process for Super Colon Cleanse Stimulant Laxative after a December 2017 formulation change. Process validation protocols and reports were issued a year late, using data from the previous formulation. 3. **Failure to validate test methods (21 CFR 211.165(e)):** The assay method for Super Colon Cleanse laxative was not adequately validated, with discrepancies in wavelength used and lack of system suitability. 4. **Inadequate stability testing program (2