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FDA Inspection
•Fertility Center of Orlando•November 21, 2023

Fertility Center of Orlando – FDA Inspection, Nov 21, 2023

Record Details

This FDA Inspection record concerns Fertility Center of Orlando, with an inspection on November 21, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Fertility Center of Orlando
Inspection Date
November 21, 2023
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Mizanne E. Lewis (Company Rep)
View Company Profile

ID · ad2ae0db-cba7-4dad-a1f1-4056fac268fe

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1223210
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

4
  1. 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
  2. 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
  3. 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
  4. 21 CFR 1271.75(a)(1)Risk factors, clinical evidence

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Fertility Center of Orlando

3
DateClassificationOfficeProject area
October 5, 2017NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
March 30, 2016NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
July 23, 2014NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Fertility Center of Orlando
  • FDA Inspection 1032324 - 2017-10-05
  • FDA Inspection 964140 - 2016-03-30
  • FDA Inspection 888331 - 2014-07-23

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