FDA Inspection
Denker, Mark S, MD PADenker, Mark S, MD PA – FDA Inspection, May 24, 2018
Record Details
This FDA Inspection record concerns Denker, Mark S, MD PA, with an inspection on May 24, 2018, issued by the Florida District Office, covering biologics.
- Office
- Florida District Office
- Person
- Colleen M. Aspinwall (Issuing Officer)
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ID · 9c6902e1-d8f4-4476-a5f7-8fcab096360d
Inspection Facts
- Inspection number
- 1053058
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.50(b)(1)Donor screening standards
- 21 CFR 1271.55(a)(2)Eligibility statement--basis of determination
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
- 21 CFR 1271.55(b)(4)Reasons for ineligibility on summary
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
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Other FDA inspections of Denker, Mark S, MD PA
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 6, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 6, 2022 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 18, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 5, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Denker, Mark S, MD PA
- FDA Inspection 1326478 - 2026-07-14
- FDA Inspection 1207527 - 2023-06-06
- FDA Inspection 1171177 - 2022-06-06
- FDA Inspection 949687 - 2015-11-18
- FDA Inspection 755670 - 2011-12-05
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