FDA Inspection
Chelsea Fertility NYCChelsea Fertility NYC – FDA Inspection, Sep 28, 2018
Record Details
This FDA Inspection record concerns Chelsea Fertility NYC, with an inspection on September 28, 2018, issued by the New York District Office, covering biologics.
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ID · fcd53658-2b6c-47df-96af-1ecbf526164b
Inspection Facts
- Inspection number
- 1067008
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(a)Infection with communicable disease agents
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Other FDA inspections of Chelsea Fertility NYC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 22, 2024 | VAI | New York District Office | Human Cellular, Tissue, and Gene Therapies |
| October 11, 2022 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 17, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 16, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Chelsea Fertility NYC
- FDA Inspection 1254995 - 2024-11-22
- FDA Inspection 1181207 - 2022-10-11
- FDA Inspection 1094868 - 2019-05-17
- FDA Inspection 982017 - 2016-08-16
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