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FDA Inspection
•California Fertility Experts, Inc.•August 25, 2023

California Fertility Experts, Inc. – FDA Inspection, Aug 25, 2023

Record Details

This FDA Inspection record concerns California Fertility Experts, Inc., with an inspection on August 25, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
California Fertility Experts, Inc.
Inspection Date
August 25, 2023
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Shelley H. Beausoleil (Issuing Officer)
View Company Profile

ID · 8e16ba10-813b-476d-9703-ac6737468556

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1215863
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 1271.80(c)Manufacturer instructions not followed
  2. 21 CFR 1271.80(c)Manufacturer instructions not followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of California Fertility Experts, Inc.

3
DateClassificationOfficeProject area
February 26, 2025Not classifiedLos Angeles District Office
August 1, 2018NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
September 28, 2015NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for California Fertility Experts, Inc.
  • FDA Inspection 1263375 - 2025-02-26
  • FDA Inspection 1069111 - 2018-08-01
  • FDA Inspection 944132 - 2015-09-28

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