# FDA 483 - Lovelace Biomedical Research Institute - September 13, 2019

Source: https://www.keypedia.com/records/483/lovelace-biomedical-research-institute/2cc69e59-a746-45c0-8ae0-e016b5b84b9e

> FDA 483 for Lovelace Biomedical Research Institute on September 13, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lovelace Biomedical Research Institute
- Inspection Date: 2019-09-13
- Product Type: other
- Office Name: Denver District Office
- Summary: Lovelace Respiratory Research Institute was cited for deficiencies in assuring data integrity and maintaining quality assurance during nonclinical laboratory studies. The inspection revealed that the study director failed to ensure accurate recording and verification of experimental data, specifically regarding test article preparation. Furthermore, the quality assurance unit did not maintain a complete master schedule for all nonclinical laboratory studies.

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## Related Officers

- [issuing_officer](https://www.keypedia.com/people/zhou-chen/03362438-eba1-4010-b6b1-5cccf25a824c)
- [Investigator ](https://www.keypedia.com/people/dustin-tran/52b41643-a5f9-4b2e-8da4-24beca42b1cd)
- [issuing_officer](https://www.keypedia.com/people/ruth-a-williams/f6dd5e30-fe9a-4b18-9703-dc471a55f24f)
- [investigator](https://www.keypedia.com/people/jeanne-j-thai/f7b057a4-ab4c-43de-a448-384ff9f8598f)

Company: https://www.keypedia.com/companies/lovelace-biomedical-research-institute/3d1ce1c8-86cd-403c-b468-d2b26ef4c77c

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