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, Feb 22, 2024
Record Details
This FDA Inspection record concerns Zhang Medical P.C. d/b/a New Hope Fertility Center, with an inspection on February 22, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 22, 2024
- Product Type
- Biologics
View Company Profile
ID · e069a55b-67b8-43a8-8442-7b5e287d5699
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1230684
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Zhang Medical P.C. d/b/a New Hope Fertility Center
6| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| September 15, 2014 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Zhang Medical P.C. d/b/a New Hope Fertility Center
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.