FDA Inspection
Lovelace Biomedical Research InstituteLovelace Biomedical Research Institute – FDA Inspection, Sep 13, 2019
Record Details
This FDA Inspection record concerns Lovelace Biomedical Research Institute, with an inspection on September 13, 2019, issued by the Denver District Office, covering human drugs.
- Inspection Date
- September 13, 2019
- Product Type
- Human Drugs
- Office
- Denver District Office
- People
- Dustin P. Tran (Issuing Officer)
- Jeanne J. Thai (Company Rep)
- Ruth A. Williams (Company Rep)
- Zhou Chen (Company Rep)
View Company Profile
ID · 765a21f2-b44c-4977-81fd-b38380d4a9af
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101842
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 58.33(b)Study director: all data recorded and verified
- 21 CFR 58.35(b)(1)QAU: maintain a master schedule
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Lovelace Biomedical Research Institute
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2025 | Not classified | Denver District Office | Bioresearch Monitoring: Human Drugs |
| September 14, 2023 | Not classified | Denver District Office | |
| January 31, 2020 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 11, 2016 | Not classified | Denver District Office |
Other documents for Lovelace Biomedical Research Institute
- FDA Inspection 1267403 - 2025-04-18
- FDA Inspection 1220523 - 2023-09-14
- FDA Inspection 1118971 - 2020-01-31
- FDA Inspection 998362 - 2016-11-11
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