Company
United StatesDenker, Mark S, MD PA, Boca Raton, FL – FDA Inspections
Inspection records and compliance data for Denker, Mark S, MD PA in Boca Raton, Florida. 7 FDA inspections on record (1 OAI), 1 Form 483, last inspected July 14, 2026.
Company Profile
This profile covers Denker, Mark S, MD PA based in Boca Raton, Florida, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 1
- VAI
- 1
- NAI
- 4
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 23, 2009. Last inspected July 14, 2026.
Most cited issue areas
- Donor screening standards2 inspections
- Determination based on screening and testing1 inspection
- Donors with risks not determined ineligible1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 14, 2026 | NAI | · Human Cellular, Tissue, and Gene Therapies | 1326478 |
| June 6, 2023 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1207527 |
| June 6, 2022 | OAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1171177 |
| May 24, 2018 | Not classified | Biologics · Blood and Blood Products | 1053058 |
| November 18, 2015 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 949687 |
| December 5, 2011 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 755670 |
| July 23, 2009 | NAI | Biologics · Blood and Blood Products | 598743 |
FDA documents
Form 483s (1)
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Company Information
Name
Denker, Mark S, MD PA
FEI Number
3004450713
Address
7015 Beracasa Way Ste 201, Boca Raton, Florida 33433, United States
Country
United States
ID: e1f0e1f4-aad1-411d-bf14-7d4600c51408