# FDA 483 - Redbeast Enterprises Inc dba High Quality Research - February 27, 2023

Source: https://www.globalkeysolutions.net/records/483/redbeast-enterprises-inc-dba-high-quality-research/11b12ff6-f0c0-4f40-8b09-749b932d632e

> FDA 483 for Redbeast Enterprises Inc dba High Quality Research on February 27, 2023. 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: 2023-02-27
- Product Type: other
- Office Name: Denver District Office
- Summary: Redbeast Enterprises Inc dba High Quality Research, a nonclinical laboratory in Fort Collins, CO, was cited for numerous violations of FDA Good Laboratory Practice (GLP) regulations during an inspection from February 14-27, 2023. The observations primarily concern deficiencies in quality assurance unit operations, study director responsibilities, record keeping, and personnel management. These issues indicate significant systemic problems in ensuring the integrity and reliability of nonclinical laboratory studies.

## Related Documents

- [EIR - 2021-07-26](https://www.globalkeysolutions.net/records/eir/redbeast-enterprises-inc-dba-high-quality-research/1f43953b-356f-4149-a746-dd135d92b623)
- [483 - 2021-07-26](https://www.globalkeysolutions.net/records/483/redbeast-enterprises-inc-dba-high-quality-research/09b926cc-5ddf-47fb-a872-9c159b4a26b1)

## Related Officers

- [Theressa B. Smith](https://www.globalkeysolutions.net/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

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

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