# FDA 483 - Colorado Histo-Prep - May 10, 2013

Source: https://www.globalkeysolutions.net/records/483/colorado-histo-prep/a0595f0d-97da-42c3-a741-434708326494

> FDA 483 for Colorado Histo-Prep on May 10, 2013. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Colorado Histo-Prep
- Inspection Date: 2013-05-10
- Product Type: other
- Office Name: Denver District Office
- Summary: An FDA inspection of Colorado Histo-Prep, a GLP Contract Facility in Fort Collins, CO, revealed extensive deficiencies across its operations. The firm failed to adequately manage its quality assurance unit, ensure proper conduct of nonclinical laboratory studies, maintain appropriate personnel training, validate and maintain equipment, and establish comprehensive standard operating procedures. These issues indicate a systemic lack of adherence to Good Laboratory Practice regulations, impacting data integrity and study reliability.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/colorado-histo-prep/db9959d6-65e7-46e4-804d-76c0696aa590

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