FDA Inspection 1247743 — Marwan M. Shaykh, M.D.
The FDA completed an inspection of Marwan M. Shaykh, M.D. on August 28, 2024 in Jacksonville, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 28, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Jacksonville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12290 | 21 CFR 1271.80(d)(1) | Reactive tests--not determined ineligible |
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |
| 12494 | 21 CFR 1271.85(c) | Reproductive cells or tissues |