FDA Inspection
Zhang Medical P.C. d/b/a New Hope Fertility CenterZhang Medical P.C. d/b/a New Hope Fertility Center – FDA Inspection, Sep 15, 2014
Record Details
This FDA Inspection record concerns Zhang Medical P.C. d/b/a New Hope Fertility Center, with an inspection on September 15, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 15, 2014
- Product Type
- Biologics
View Company Profile
ID · 710c0e3d-3efd-4a1c-99d6-4397d9cd42a2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 895283
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.75(c)Reproductive cells/tissues-Chlamydia, Neisseria
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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Other FDA inspections of Zhang Medical P.C. d/b/a New Hope Fertility Center
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 22, 2024 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 3, 2023 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 30, 2021 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 13, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 31, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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