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FDA Inspection
•Center for Reproductive Medicine•March 16, 2010

Center for Reproductive Medicine – FDA Inspection, Mar 16, 2010

Record Details

This FDA Inspection record concerns Center for Reproductive Medicine, with an inspection on March 16, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Center for Reproductive Medicine
Inspection Date
March 16, 2010
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 942f929f-110a-4cbc-8f86-38b49ca5d54c

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
654606
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

2
  1. 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
  2. 21 CFR 1271.47(a)Procedures for all other requirements

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Center for Reproductive Medicine

5
DateClassificationOfficeProject area
February 6, 2025Not classifiedMinneapolis District Office
October 2, 2019NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
September 1, 2017NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
July 31, 2014NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
August 6, 2012NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Center for Reproductive Medicine
  • FDA Inspection 1260495 - 2025-02-06
  • FDA Inspection 1107360 - 2019-10-02
  • FDA Inspection 1025777 - 2017-09-01
  • FDA Inspection 889603 - 2014-07-31
  • FDA Inspection 795285 - 2012-08-06

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