# FDA 483 - Health Plus Incorporated - April 21, 2023

Source: https://www.keypedia.com/records/483/health-plus-incorporated/46c1937b-5138-40da-bb3b-585c20219c04

> FDA 483 for Health Plus Incorporated on April 21, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Health Plus Incorporated
- Inspection Date: 2023-04-21
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Documents

- [483 - 2018-10-20](https://www.keypedia.com/records/483/health-plus-incorporated/0d237597-e637-42bd-927c-531d74763b49)
- [483 - 2021-07-01](https://www.keypedia.com/records/483/health-plus-incorporated/d2e94129-ee66-4f7f-817b-7c909fa120cd)

## Related Officers

- [Drug Enforcement Administration](https://www.keypedia.com/people/john-a-gonzalez/51074472-cb23-4b72-8ca7-2d973670063e)

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