# FDA 483 - Health Plus Incorporated - July 01, 2021

Source: https://www.keypedia.com/records/483/health-plus-incorporated/d2e94129-ee66-4f7f-817b-7c909fa120cd

> FDA 483 for Health Plus Incorporated on July 01, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Health Plus Incorporated
- Inspection Date: 2021-07-01
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Documents

- [483 - 2018-10-20](https://www.keypedia.com/records/483/health-plus-incorporated/0d237597-e637-42bd-927c-531d74763b49)
- [483 - 2023-04-21](https://www.keypedia.com/records/483/health-plus-incorporated/46c1937b-5138-40da-bb3b-585c20219c04)

## Related Officers

- [Professor](https://www.keypedia.com/people/liming-zhang/6c93b721-8725-4d87-8a42-254f3de5e49d)

Company: https://www.keypedia.com/companies/health-plus-incorporated/c3923de0-d30e-4ef5-8420-9874fb19e82c

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6