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 13, 2018
Record Details
This FDA Inspection record concerns Zhang Medical P.C. d/b/a New Hope Fertility Center, with an inspection on September 13, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 13, 2018
- Product Type
- Biologics
View Company Profile
ID · 7b526a63-899e-4fe5-b9d4-1091f35b900d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065547
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.55(c)Name and personal info on accompanying records
- 21 CFR 1271.50(a)Responsible person to determine, document
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 |
|---|---|---|---|
| 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 |
| 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.