FDA Inspection 1171177 — Mark S. Denker, MD PA
The FDA completed an inspection of Mark S. Denker, MD PA on June 6, 2022 in Boca Raton, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 6, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Boca Raton, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12231 | 21 CFR 1271.50(b)(1) | Donor screening standards |
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12241 | 21 CFR 1271.55(b)(4) | Reasons for ineligibility on summary |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |