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FDA Inspection
•Embryology Laboratory, LLC•May 23, 2019

Embryology Laboratory, LLC – FDA Inspection, May 23, 2019

Record Details

This FDA Inspection record concerns Embryology Laboratory, LLC, with an inspection on May 23, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Embryology Laboratory, LLC
Inspection Date
May 23, 2019
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Kathleen B. Swat (FDA Associated Person)
View Company Profile

ID · 2b32a288-9aa4-4ad8-ab7f-f23d98bbfde2

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1090914
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 1271.85(a)Infection with communicable disease agents

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Embryology Laboratory, LLC

2
DateClassificationOfficeProject area
February 23, 2026NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
November 16, 2016NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Embryology Laboratory, LLC
  • FDA Inspection 1305478 - 2026-02-23
  • FDA Inspection 993224 - 2016-11-16

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