FDA Inspection
Marwan M. Shaykh, M.D. dba Assisted Fertility ProgramMarwan M. Shaykh, M.D. dba Assisted Fertility Program – FDA Inspection, Feb 25, 2015
Record Details
This FDA Inspection record concerns Marwan M. Shaykh, M.D. dba Assisted Fertility Program, with an inspection on February 25, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 25, 2015
- Product Type
- Biologics
View Company Profile
ID · 987932d8-90cb-4c68-b979-c62be964e434
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 916043
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.50(a)Responsible person to determine, document
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Marwan M. Shaykh, M.D. dba Assisted Fertility Program
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 28, 2024 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 13, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 1, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 14, 2009 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Marwan M. Shaykh, M.D. dba Assisted Fertility Program
- FDA Inspection 1247743 - 2024-08-28
- FDA Inspection 1112318 - 2019-11-13
- FDA Inspection 1034786 - 2017-11-01
- FDA Inspection 632922 - 2009-12-14
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.