FDA Inspection
Brown Urology, Inc.Brown Urology, Inc. – FDA Inspection, Jul 2, 2018
Record Details
This FDA Inspection record concerns Brown Urology, Inc., with an inspection on July 2, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · a6a890b6-0b30-4168-bed1-885b45a083f0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1057869
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.50(b)(1)Donor screening standards
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Brown Urology, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 20, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 7, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 24, 2020 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 11, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 15, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Brown Urology, Inc.
- FDA Inspection 1315384 - 2026-04-20
- FDA Inspection 1211175 - 2023-07-07
- FDA Inspection 1119515 - 2020-01-24
- FDA Inspection 971967 - 2016-05-11
- FDA Inspection 810567 - 2012-11-15
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