FDA Inspection 949687 — Denker, Mark S, MD PA
The FDA completed an inspection of Denker, Mark S, MD PA on November 18, 2015 in Boca Raton, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 18, 2015
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Boca Raton, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12231 | 21 CFR 1271.50(b)(1) | Donor screening standards |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |