FDA Inspection
UCARM Stapleton ClinicUCARM Stapleton Clinic – FDA Inspection, Mar 3, 2014
Record Details
This FDA Inspection record concerns UCARM Stapleton Clinic, with an inspection on March 3, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- UCARM Stapleton Clinic
- Inspection Date
- March 3, 2014
- Product Type
- Biologics
View Company Profile
ID · e0141a3c-3d4f-4ae5-94b0-16536c1642ec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 868586
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.47(b)Review and approval of procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of UCARM Stapleton Clinic
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 26, 2020 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 10, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for UCARM Stapleton Clinic
- FDA Inspection 1122658 - 2020-02-26
- FDA Inspection 998147 - 2017-01-10
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