# FDA 483 - Redbeast Enterprises Inc dba High Quality Research - July 26, 2021

Source: https://www.keypedia.com/records/483/redbeast-enterprises-inc-dba-high-quality-research/09b926cc-5ddf-47fb-a872-9c159b4a26b1

> FDA 483 for Redbeast Enterprises Inc dba High Quality Research on July 26, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Redbeast Enterprises Inc dba High Quality Research
- Inspection Date: 2021-07-26
- Product Type: other
- Office Name: Denver District Office
- Summary: Redbeast Enterprises Inc dba High Quality Research in Fort Collins, CO, a nonclinical laboratory, received a Form 483 with five observations. The inspection revealed significant deficiencies in final study report documentation, including missing signed reports, descriptions of data integrity impacts, and personnel names. Additionally, the firm lacked adequate standard operating procedures for laboratory methods and failed to ensure proper training and experience for personnel involved in nonclinical studies.

## Related Documents

- [EIR - 2021-07-26](https://www.keypedia.com/records/eir/redbeast-enterprises-inc-dba-high-quality-research/1f43953b-356f-4149-a746-dd135d92b623)
- [483 - 2023-02-27](https://www.keypedia.com/records/483/redbeast-enterprises-inc-dba-high-quality-research/11b12ff6-f0c0-4f40-8b09-749b932d632e)

## Related Officers

- [Jonathan R. Campos](https://www.keypedia.com/people/jonathan-r-campos/f4c6aba7-d0fe-43d2-95ae-5eb86a6659a4)

Company: https://www.keypedia.com/companies/redbeast-enterprises-inc-dba-high-quality-research/e6ca23b1-b6a5-436b-96d2-b5acc45c50df

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face