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# Health Plus Inspection Violations
- URL: https://www.fdaweb.com/health-plus-inspection-violations/
- Published: 2022-01-25T12:00:00.000Z
- Updated: 2026-09-14T17:29:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150994

An FDA 6/23-7/1/21 inspection at the Health Plus drug manufacturing facility in Chino, CA, found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. A just-released 12/29/21 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/health-plus-inc-616877-12292021?ref=fdaweb.com) says specific violations were: 

- failing to ensure that returned drugs meet appropriate standards of safety, identity, strength, quality, and purity before redistributing;
- failing to establish adequate written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess, and the firm’s quality control unit did not review and approve the procedures, including any changes;
- failing to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods;
- failing to follow a written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates; and
- failure of the firm’s quality control unit to approve or reject all procedures or specifications affecting the identity, strength, quality, and purity of a drug product.

The letter says the agency raised similar CGMP observations in a 2018 inspection and the company proposed specific remediations for those observations at that time. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” FDA says.

The agency recommends that the firm retain a qualified consultant to perform a comprehensive audit of its entire operation for CGMP compliance and assist it in meeting the requirements.

Health Plus was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.