# FDA 483 - Front Range Laboratories, Incorporated - March 20, 2020

Source: https://www.keypedia.com/records/483/front-range-laboratories-incorporated/faa7118b-7bca-4b48-af4c-de7c3c3c61af

> FDA 483 for Front Range Laboratories, Incorporated on March 20, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Front Range Laboratories, Incorporated
- Inspection Date: 2020-03-20
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Front Range Laboratories, Incorporated in Loveland, CO, received an FDA Form 483 citing significant deficiencies during an inspection. Observations included inadequate validation of test methods for drug products like Hydromorphone HCl and Fentanyl Citrate, and a lack of established procedures to prevent microbiological contamination for sterile products. Additionally, the firm failed to ensure the accuracy of data inputs and outputs, specifically regarding unvalidated Excel spreadsheets used for critical calculations.

## Related Documents

- [483 - 2013-08-30](https://www.keypedia.com/records/483/front-range-laboratories-incorporated/8bdc1a1a-4970-4a2a-a9b6-411b61f79f13)
- [483 - 2020-03-20](https://www.keypedia.com/records/483/front-range-laboratories-incorporated/4e3fa58f-4c66-406c-8beb-b25e5a8497e2)

## Related Officers

- [Senior Lead Reviewer and Intercenter Consult Team Leader](https://www.keypedia.com/people/nayan-j-patel/0436f014-4b1b-4e54-8df0-576d51a354b2)
- [Chemist/Investigator - Pharmaceutical Quality](https://www.keypedia.com/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)

Company: https://www.keypedia.com/companies/front-range-laboratories-incorporated/1949590b-5a12-4d7a-8607-ce56c9e4ee5d

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