FDA Inspection
Bethesda Fertility CenterFDA Inspection 1200793 - Bethesda Fertility Center - March 22, 2023
Record Details
This FDA Inspection record concerns Bethesda Fertility Center, with an inspection on March 22, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · db3e6e1e-5e4f-4fae-a5ec-356314cb87c1
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1200793
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 1271.55(b)(4)Reasons for ineligibility on summary
- 21 CFR 1271.65(a)Improper release prevention--storage, I.D.
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.75(e)Abbreviated procedure
- 21 CFR 1271.80(b)Specimen collections not timely
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bethesda Fertility Center
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 23, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 7, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 4, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 17, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 28, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Bethesda Fertility Center
- FDA Inspection 1107936 - 2019-10-23
- FDA Inspection 1031746 - 2017-11-07
- FDA Inspection 951136 - 2015-12-04
- FDA Inspection 859215 - 2013-12-17
- FDA Inspection 760522 - 2011-12-28
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