# FDA 483 - Integrated Health Concepts Inc. - September 25, 2019

Source: https://www.globalkeysolutions.net/records/483/integrated-health-concepts-inc/bc17aea4-720f-4cc1-8929-53ae0628c74a

> FDA 483 for Integrated Health Concepts Inc. on September 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Integrated Health Concepts Inc.
- Inspection Date: 2019-09-25
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: The inspection of Integrated Health Concepts Inc. dba Conversio Health in San Luis Obispo, CA, a producer of sterile drugs, revealed significant deficiencies in aseptic processing and environmental controls. Observations included inadequate cleanroom design, insufficient sterilization methods, lack of environmental monitoring, and failures in media fill simulations, indicating a high risk of product contamination. These issues suggest a serious lack of control over sterile drug production.

## Related Documents

- [483 - 2021-07-23](https://www.globalkeysolutions.net/records/483/integrated-health-concepts-inc/178c4cd5-5d06-469f-93da-cea1a3118e45)
- [483 - 2021-07-23](https://www.globalkeysolutions.net/records/483/integrated-health-concepts-inc/6f2541a9-a292-4e08-badb-486b0b667650)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/integrated-health-concepts-inc/550115a1-4bb0-403a-a67e-31e487ce43ab

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b