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FDA Inspection
•Viera Fertility Center•November 12, 2009

Viera Fertility Center – FDA Inspection, Nov 12, 2009

Record Details

This FDA Inspection record concerns Viera Fertility Center, with an inspection on November 12, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Viera Fertility Center
Inspection Date
November 12, 2009
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 583604f5-82a2-4d87-9e39-731bb67ca940

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
627284
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

5
  1. 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
  2. 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
  3. 21 CFR 1271.85(a)Infection with communicable disease agents
  4. 21 CFR 1271.47(a)Procedures for all other requirements
  5. 21 CFR 1271.150(c)(1)(iii)Ensurane of compliance

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Viera Fertility Center

6
DateClassificationOfficeProject area
March 20, 2025NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
February 3, 2023VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
June 5, 2019VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
May 17, 2017VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
March 19, 2015VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
View all 6 other inspections on the company page
Other documents for Viera Fertility Center
  • FDA Inspection 1265437 - 2025-03-20
  • FDA Inspection 1196576 - 2023-02-03
  • FDA Inspection 1092685 - 2019-06-05
  • FDA Inspection 1021313 - 2017-05-17
  • FDA Inspection 918464 - 2015-03-19

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