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FDA Inspection
•CT Fertility, PC•December 11, 2015

CT Fertility, PC – FDA Inspection, Dec 11, 2015

Record Details

This FDA Inspection record concerns CT Fertility, PC, with an inspection on December 11, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
CT Fertility, PC
Inspection Date
December 11, 2015
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 488c9b31-516d-4bc2-8c2d-7a89b1a25375

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
952131
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

3
  1. 21 CFR 1271.55(d)(2)Accurate, indelible, legible
  2. 21 CFR 1271.55(c)Name and personal info on accompanying records
  3. 21 CFR 1271.50(a)Responsible person to determine, document

Full citation text and observation details available on the Dashboard.

Other FDA inspections of CT Fertility, PC

4
DateClassificationOfficeProject area
December 14, 2017NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
June 19, 2013NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
May 6, 2011NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
July 22, 2009NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for CT Fertility, PC
  • FDA Inspection 1036603 - 2017-12-14
  • FDA Inspection 836643 - 2013-06-19
  • FDA Inspection 723638 - 2011-05-06
  • FDA Inspection 598870 - 2009-07-22

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