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FDA Inspection
•Delaware Institute for Reproductive Medicine, P.A•June 20, 2019

Delaware Institute for Reproductive Medicine, P.A – FDA Inspection, Jun 20, 2019

Record Details

This FDA Inspection record concerns Delaware Institute for Reproductive Medicine, P.A, with an inspection on June 20, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Delaware Institute for Reproductive Medicine, P.A
Inspection Date
June 20, 2019
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Erika M. Wilkerson (Company Rep)
View Company Profile

ID · 637058bc-c8e1-4b70-9344-456c2eccbe8a

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1094217
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 1271.75(a)(1)Risk factors, clinical evidence

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Delaware Institute for Reproductive Medicine, P.A

6
DateClassificationOfficeProject area
September 16, 2025NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
October 26, 2022NAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
June 8, 2017NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
May 13, 2015NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
May 16, 2013NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
View all 6 other inspections on the company page
Other documents for Delaware Institute for Reproductive Medicine, P.A
  • FDA Inspection 1293390 - 2025-09-16
  • FDA Inspection 1187482 - 2022-10-26
  • FDA Inspection 1018967 - 2017-06-08
  • FDA Inspection 925928 - 2015-05-13
  • FDA Inspection 831892 - 2013-05-16

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