FDA Inspection
Marwan M. Shaykh, M.D. dba Assisted Fertility ProgramMarwan M. Shaykh, M.D. dba Assisted Fertility Program – FDA Inspection, Aug 28, 2024
Record Details
This FDA Inspection record concerns Marwan M. Shaykh, M.D. dba Assisted Fertility Program, with an inspection on August 28, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 28, 2024
- Product Type
- Biologics
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ID · 79e0e726-da29-463c-b706-c03cdf58d4ad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1247743
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.47(b)Review and approval of procedures
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.80(d)(1)Reactive tests--not determined ineligible
- 21 CFR 1271.85(c)Reproductive cells or tissues
- 21 CFR 1271.150(c)(1)(iii)Ensurane of compliance
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 |
|---|---|---|---|
| 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 |
| February 25, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| 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 1112318 - 2019-11-13
- FDA Inspection 1034786 - 2017-11-01
- FDA Inspection 916043 - 2015-02-25
- FDA Inspection 632922 - 2009-12-14
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