# FDA 483 - Receptor Holdings Inc. DBA Receptor Life Sciences, Inc - July 07, 2021

Source: https://www.globalkeysolutions.net/records/483/receptor-holdings-inc-dba-receptor-life-sciences-inc/8b19d5a4-d34f-4c60-b1da-88d6460762ae

> FDA 483 for Receptor Holdings Inc. DBA Receptor Life Sciences, Inc on July 07, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Receptor Holdings Inc. DBA Receptor Life Sciences, Inc
- Inspection Date: 2021-07-07
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Receptor Holdings Inc. DBA Receptor Life Sciences, Inc in Seattle, WA, was cited for a significant regulatory violation during an FDA inspection. The firm conducted a clinical investigation involving an investigational new drug with 35 subjects between August 2019 and March 2020 without first submitting an Investigational New Drug (IND) application to the FDA. This indicates a serious failure to comply with regulatory requirements for clinical trials.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/sunitha-k-rajaram/1a0872d4-5e7b-4690-a2be-3877aec25053)

Company: https://www.globalkeysolutions.net/companies/receptor-holdings-inc-dba-receptor-life-sciences-inc/efc08c7b-9854-40d2-a708-39585ba462f9

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822