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FDA Inspection
•Los Angeles Reproductive Center•December 12, 2023

Los Angeles Reproductive Center – FDA Inspection, Dec 12, 2023

Record Details

This FDA Inspection record concerns Los Angeles Reproductive Center, with an inspection on December 12, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Los Angeles Reproductive Center
Inspection Date
December 12, 2023
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Kaarin M. Slotte (Company Rep)
View Company Profile

ID · f289edfe-565a-4161-9656-1480a6dc60cb

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1224904
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued

FDA Citations

4
  1. 21 CFR 1271.75(d)Donors with risks not determined ineligible
  2. 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
  3. 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
  4. 21 CFR 1271.75(d)Donors with risks not determined ineligible

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Los Angeles Reproductive Center

1
DateClassificationOfficeProject area
October 17, 2018NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Los Angeles Reproductive Center
  • FDA Inspection 1072891 - 2018-10-17

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