# FDA 483 - In VitroTech Labs, Inc. - March 21, 2018

Source: https://www.keypedia.com/records/483/in-vitrotech-labs-inc/37ff6a4e-052b-41cb-8f8f-83d3aca3b310

> FDA 483 for In VitroTech Labs, Inc. on March 21, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: In VitroTech Labs, Inc.
- Inspection Date: 2018-03-21
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of In VitroTech Labs, Inc. in West Hollywood, CA, revealed a significant compliance issue related to the distribution of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to ensure that distributed HCT/Ps were accompanied by the required donor-eligibility determination and a complete summary of records for oocyte donors. This indicates a lapse in critical documentation practices for human reproductive tissue.

## Related Officers

- [Investigator](https://www.keypedia.com/people/peter-s-kessler/f3a9dea7-3a2d-4c86-9ec6-97791f9b6c21)

Company: https://www.keypedia.com/companies/in-vitrotech-labs-inc/a5801e26-8af0-4d96-a20f-225b8355f8f4

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