# FDA 483 - Integrated Health Concepts Inc. - July 23, 2021

Source: https://www.keypedia.com/records/483/integrated-health-concepts-inc/178c4cd5-5d06-469f-93da-cea1a3118e45

> FDA 483 for Integrated Health Concepts Inc. on July 23, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Integrated Health Concepts Inc.
- Inspection Date: 2021-07-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Integrated Health Concepts Inc. in San Luis Obispo, CA, a producer of sterile drugs, identified two observations related to aseptic processing. The firm was cited for personnel failing to sanitize gloves after touching non-aseptic surfaces before handling materials in an ISO 5 area, and for blocking critical airflow within a Biological Safety Cabinet during sterile drug compounding.

## Related Documents

- [483 - 2019-09-25](https://www.keypedia.com/records/483/integrated-health-concepts-inc/bc17aea4-720f-4cc1-8929-53ae0628c74a)
- [483 - 2021-07-23](https://www.keypedia.com/records/483/integrated-health-concepts-inc/6f2541a9-a292-4e08-badb-486b0b667650)

## Related Officers

- [Investigator](https://www.keypedia.com/people/jolanna-a-norton/5501fea4-4bfd-434c-b2aa-fcf94444f684)
- [Stryker, Regulatory Affairs](https://www.keypedia.com/people/gunneet-kaur/e2823ed9-44f2-4553-8984-895ef8c7eece)

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

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