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FDA Inspection
•North Carolina Center for Reproductive Medicine Inc (NCCRM)•July 11, 2014

North Carolina Center for Reproductive Medicine Inc (NCCRM) – FDA Inspection, Jul 11, 2014

Record Details

This FDA Inspection record concerns North Carolina Center for Reproductive Medicine Inc (NCCRM), with an inspection on July 11, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
North Carolina Center for Reproductive Medicine Inc (NCCRM)
Inspection Date
July 11, 2014
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · af31db0b-3fe8-46f4-806c-9158f3c922df

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
886807
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

4
  1. 21 CFR 1271.80(b)Specimen collections not timely
  2. 21 CFR 1271.85(a)Infection with communicable disease agents
  3. 21 CFR 1271.90(c)Eligibility not required--warning labels
  4. 21 CFR 1271.75(e)Abbreviated procedure

Full citation text and observation details available on the Dashboard.

Other FDA inspections of North Carolina Center for Reproductive Medicine Inc (NCCRM)

5
DateClassificationOfficeProject area
January 22, 2025NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
January 26, 2023NAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
March 16, 2020NAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
February 6, 2018VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
May 5, 2016NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for North Carolina Center for Reproductive Medicine Inc (NCCRM)
  • FDA Inspection 1259321 - 2025-01-22
  • FDA Inspection 1195608 - 2023-01-26
  • FDA Inspection 1121058 - 2020-03-16
  • FDA Inspection 1040135 - 2018-02-06
  • FDA Inspection 968307 - 2016-05-05

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